PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Report
- Report Number
- 1020279-2025-01704
- Event Type
- Injury
- Date Received
- October 15, 2025
- Report Date
- October 28, 2025
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HSX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01704, PREVIOUSLY SUBMITTED ON 14-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN THE ATTACHED CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE-ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: CASE-(B)(4). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01704.
REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025) . SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY JOINT REPLACEMENT PROCEDURES: 1. PRIMARY UKA PROCEDURES: GENESIS UNI FEMORAL COMPONENTS: A TOTAL OF TWO THOUSAND ONE HUNDRED AND NINETY-EIGHT (2198) KNEES BETWEEN 15-NOV-1999 AND 03-FEB-2014. THIS INCLUDES GENESIS UNI FEMORAL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES HSX, JWH AND JDI. FROM THESE, FIVE HUNDRED SIX (506) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED AND EIGHTY-SEVEN (187) KNEES DUE TO PROGRESSION OF DISEASE, TWO HUNDRED AND EIGHTEEN (218) KNEES DUE TO LOOSENING, THIRTY (30) KNEES DUE TO PAIN, TWELVE (12) KNEES DUE TO INFECTION, FOURTEEN (14) KNEES DUE TO LYSIS, THREE (3) KNEES DUE TO FRACTURE, NINE (9) KNEES DUE TO WEAR OF TIBIAL INSERT, FIVE (5) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO MALALIGNMENT, FIVE (5) KNEES DUE TO IMPLANT BREAKAGE ASSOCIATED WITH THE TIBIAL COMPONENT, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, FOUR (4) KNEES DUE TO TIBIAL WEAR, TWO (2) KNEES DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO INCORRECT SIZING, FIVE (5) KNEES DUE TO OSTEONECROSIS, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO PATELLA EROSION AND TWO (2) KNEES DUE TO OTHER-UNSPECIFIED REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 506 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 122 REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS UNI FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE HSX. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 122 CASES. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE GENESIS UNI KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR REPORTS FOR THE GENESIS UNICOMPARTMENTAL KNEE SYSTEM A TOTAL NUMBER OF 2,198 PROCEDURES. THERE WAS A MEAN FOLLOW-UP OF 13.6 YEARS (RANGE 0.10 ¿ 25.0 YEARS). AT 10 YEARS, THE REVISION RATE FOR GENESIS UNI IS 16.4% (95% CI: 14.9%-18.0%), WHICH IS STATISTICALLY SIGNIFICANTLY HIGHER THAN THE CLASS AVERAGE (12.8%; CI: 12.5%-13.1%) BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS. WHEN ADJUSTED FOR AGE AND GENDER, GENESIS UNI BEYOND 7 YEARS PERFORMED STATISTICALLY BETTER THAN THE CLASS AVERAGE BASED ON HAZARD RATIOS. THERE WERE 506 REASONS FOR REVISION (23.0%) FOR GENESIS UNI. THE MAJORITY OF PRIMARY GENESIS UNICOMPARTMENTAL KNEE SYSTEM DEVICES WERE REVISED DUE TO LOOSENING (9.9%) AND PROGRESSION OF DISEASE (8.5%). THE REPORTED TRENDS HAVE BEEN PREVIOUSLY OBSERVED IN THE MOST RECENT CLINICAL EVALUATION REPORTS AND CLINICAL EVALUATION MEMOS AND HAVE NOT INCREASED IN SEVERITY. SMITH+NEPHEW WILL CONTINUE TO MONITOR REVISIONS OCCURRING POST-IMPLANTATION. SPECIFIC ANALYSIS FOR EACH COMBINATION IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.
Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00279539-1-L1, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM PLUS,71245007, ,71245007, ,03596010188519,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L2, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM PLUS,71245007, ,71245007, ,03596010188519,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L3, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM PLUS,71245007, ,71245007, ,03596010188519,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L4, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM PLUS,71245007, ,71245007, ,03596010188519,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L5, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L6, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L7, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L8, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L9, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L10, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L11, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L12, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L13, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L14, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L15, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L16, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L17, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L18, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L19, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L20, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L21, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL SMALL,725002, ,725002, ,03596010256782,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L22, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L23, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L24, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L25, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L26, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L27, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L28, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L29, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L30, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L31, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L32, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L33, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L34, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L35, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L36, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L37, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L38, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L39, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L40, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L41, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L42, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L43, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L44, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L45, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L46, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L47, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L48, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L49, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L50, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L51, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L52, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI MEDIUM FEMORAL,725003, ,725003, ,03596010256799,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L53, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L54, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L55, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L56, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L57, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L58, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L59, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L60, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L61, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L62, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L63, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L64, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L65, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L66, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L67, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L68, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L69, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L70, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L71, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L72, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L73, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L74, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L75, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L76, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L77, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L78, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L79, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L80, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L81, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI FEMORAL LARGE,725004, ,725004, ,03596010256805,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L82, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L83, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L84, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L85, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L86, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L87, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L88, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L89, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L90, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L91, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L92, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L93, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L94, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L95, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L96, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L97, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L98, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L99, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L100, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L101, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L102, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L103, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENESIS UNI EXTRA-LARGE FEMORAL,725005, ,725005, ,03596010256812,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L104, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L105, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L106, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L107, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L108, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L109, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L110, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L111, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L112, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L113, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L114, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L115, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L116, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L117, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L118, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L119, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L120, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L121, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;CASE-2025-00279539-1-L122, ,10/14/2025,5/5/2025,GENESIS UNI Knee System,GENISIS UNI FEMORAL MAGNUM,725006, ,725006, ,03596010256829,K912735, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 3-feb-2014, using a GENESIS UNI Femoral Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two thousand one hundred and ninety-eight (2198) knees underwent primary UKA procedures between 15-Nov-1999 and 03-Feb-2014, using a GENESIS UNI Femoral Component. This includes GENESIS UNI Femoral Components approved for use in the United States under PRO codes HSX, JWH and JDI. From these, five hundred six (506) knees were later revised due to the following reasons: one hundred and eighty-seven (187) knees due to progression of disease, two hundred and eighteen (218) knees due to loosening, thirty (30) knees due to pain, twelve (12) knees due to infection, fourteen (14) knees due to lysis, three (3) knees due to fracture, nine (9) knees due to wear of tibial insert, five (5) knees due to instability, five (5) knees due to malalignment, five (5) knees due to implant breakage associated with the tibial component, two (2) knees due to patellofemoral pain, four (4) knees due to tibial wear, two (2) knees due to metal related pathology, one (1) knee due to incorrect sizing, five (5) knees due to osteonecrosis, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion and two (2) knees due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 506 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 122 revisions associated with knees that had previously received a GENESIS UNI Femoral Component approved under FDA product code HSX. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 122 cases.;Timeframe of Registry data: Implantations conducted between 15-Nov-1999 and 03-Feb-2014 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two thousand one hundred and ninety-eight (2198) UKA procedures with GENESIS UNI Femoral Components have been performed in Australia between 15-Nov-1999 and 3-feb-2014. Yearly cumulative percent revision of primary UKA for GENESIS UNI Knee System was compared to the UKA class in the AOANJRR. At 1-year, the GENESIS UNI Knee System performed in line with all other unicompartmental knees based on overlapping 95% confidence interval. From 2 through 15 years of follow-up, the GENESIS UNI Knee System show higher revision rates compared to all other unicompartmental knees, as confirmed by non-overlapping confidence intervals. From 16-22 years, the system performs in line with the UKA class based on overlapping 95% confidence interval. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 2.5% (1.9%-3.2%) vs 2.0% (1.9%-2.1%) of the class.;¿ At 2nd postoperative year: 5.6% (4.7%-6.6%) vs 3.7% (3.5%-3.8%) of the class.;¿ At 3rd postoperative year: 7.9% (6.8%-9.1%) vs 4.8% (4.7%-5.0%) of the class.;¿ At 4th postoperative year: 9.1% (8.0%-10.4%) vs 5.8% (5.7%-6.0%) of the class.;¿ At 5th postoperative year: 10.6% (9.4%-12.0%) vs 6.8% (6.7%-7.0%) of the class.;¿ At 6th postoperative year: 11.9% (10.6%-13.4%) vs 7.8% (7.6%-8.0%) of the class.;¿ At 7th postoperative year: 12.9% (11.5%-14.3%) vs 9.0% (8.7%-9.2%) of the class.;¿ At 8th postoperative year: 14.0% (12.6%-15.6%) vs 10.1% (9.9%-10.3%) of the class.;¿ At 9th postoperative year: 15.1% (13.6%-16.7%) vs 11.4% (11.2%-11.7%) of the class.;¿ At 10th postoperative year: 16.4% (14.9%-18.0%) vs 12.8% (12.5%-13.1%) of the class.;¿ At 11th postoperative year: 17.5% (15.9%-19.2%) vs 14.2% (13.9%-14.5%) of the class.;¿ At 12th postoperative year: 18.5% (16.9%-20.3%) vs 15.6% (15.3%-16.0%) of the class.;¿ At 13th postoperative year: 19.9% (18.3%-21.7%) vs 17.1% (16.7%-17.5%) of the class.;¿ At 14th postoperative year: 21.1% (19.4%-23.0%) vs 18.6% (18.3%-19.0%) of the class.;¿ At 15th postoperative year: 22.6% (20.8%-24.6%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 16th postoperative year: 23.4% (21.6%-25.4%) vs 21.6% (21.2%-22.0%) of the class.;¿ At 17th postoperative year: 24.5% (22.6%-26.5%) vs 23.2% (22.7%-23.7%) of the class.;¿ At 18th postoperative year: 25.8% (23.8%-27.9%) vs 24.7% (24.2%-25.2%) of the class.;¿ At 19th postoperative year: 27.1% (25.0%-29.4%) vs 26.2% (25.7%-26.8%) of the class.;¿ At 20th postoperative year: 27.5% (25.3%-29.8%) vs 27.6% (27.1%-28.2%) of the class.;¿ At 21st postoperative year: 28.3% (26.0%-30.8%) vs 29.0% (28.4%-29.7%) of the class.;¿ At 22nd postoperative year: 28.9% (26.4%-31.6%) vs 30.3% (29.6%-31.1%) of the class;;GENESIS Unicompartmental Knee System experienced statistically higher revision rates from six months to 7 years compared to the class when adjusted by age and gender. GENESIS Unicompartmental Knee System beyond 7 years performed statistically better than the class average based on hazard ratios adjusted for age and gender. The majority of primary GENESIS Unicompartmental Knee System devices were revised due to loosening (9.9%) and progression of disease (8.5%). The frequency of revision for loosening and progression of disease was higher than the UKA class across all follow-up years. ;;When comparing the type of UNI tibial baseplates (GENESIS, GENESIS II, JOURNEY UNI v1, JOURNEY UNI v2 or JOURNEY UNI All Poly) used in combination with the GENESIS UNI femoral components, the registry data showed that the revisions per 100 observed years remained in line with the class for all combinations based on overlapping confidence intervals. The reported trends have been previously observed in the most recent clinical evaluation reports and clinical evaluation memos and have not increased in severity. Smith+Nephew will continue to monitor revisions occurring post-implantation. Overall, the GENESIS UNI Knee System long-term survivorship (7-years and beyond, when adjusted for gender and sex) is statistically in line with the class average. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", ,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,1;
BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY JOINT REPLACEMENT PROCEDURES: 1. PRIMARY UKA PROCEDURES: GENESIS UNI FEMORAL COMPONENTS: A TOTAL OF TWO THOUSAND ONE HUNDRED AND NINETY-EIGHT (2198) KNEES BETWEEN 15-NOV-1999 AND 03-FEB-2014. THIS INCLUDES GENESIS UNI FEMORAL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES HSX, JWH AND JDI. FROM THESE, FIVE HUNDRED SIX (506) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED AND EIGHTY-SEVEN (187) KNEES DUE TO PROGRESSION OF DISEASE, TWO HUNDRED AND EIGHTEEN (218) KNEES DUE TO LOOSENING, THIRTY (30) KNEES DUE TO PAIN, TWELVE (12) KNEES DUE TO INFECTION, FOURTEEN (14) KNEES DUE TO LYSIS, THREE (3) KNEES DUE TO FRACTURE, NINE (9) KNEES DUE TO WEAR OF TIBIAL INSERT, FIVE (5) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO MALALIGNMENT, FIVE (5) KNEES DUE TO IMPLANT BREAKAGE ASSOCIATED WITH THE TIBIAL COMPONENT, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, FOUR (4) KNEES DUE TO TIBIAL WEAR, TWO (2) KNEES DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO INCORRECT SIZING, FIVE (5) KNEES DUE TO OSTEONECROSIS, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO PATELLA EROSION AND TWO (2) KNEES DUE TO OTHER-UNSPECIFIED REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 506 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 122 REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS UNI FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE HSX. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 122 CASES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2018962 | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | HSX | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Unknown |