PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Report
- Report Number
- 1020279-2025-01705
- Event Type
- Injury
- Date Received
- October 15, 2025
- Report Date
- April 30, 2026
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- KRO
- 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 1020279-2025-01705, 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: (B)(4). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE .CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01705.
REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF LEGION HK TOTAL KNEE SYSTEM IN PRIMARY AND REVISION TKA SURGERIES. 1. PRIMARY TKA PROCEDURES. A TOTAL OF TWO HUNDRED THIRTY-TWO (232) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN 02-APR-2015 AND 27-FEB-2025, USING LEGION HK TOTAL KNEE SYSTEM. FROM THESE, SIXTEEN (16) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TEN (10) KNEES DUE TO INFECTION, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO FRACTURE, ONE (1) KNEE DUE TO MALALIGNMENT, AND ONE (1) KNEE DUE TO LYSIS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE REVISIONS. 2. REVISION TKA PROCEDURES. A TOTAL OF ONE HUNDRED SIXTY-FOUR (164) KNEES UNDERWENT REVISION TKA PROCEDURES BETWEEN 10-APR-2015 AND 21-NOV-2024, USING LEGION HK TOTAL KNEE SYSTEM. FROM THESE, ELEVEN (11) KNEES WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: THREE (3) KNEES DUE TO LOOSENING, FIVE (5) KNEES DUE TO INFECTION, ONE (1) KNEE DUE TO PAIN, ONE (1) KNEE DUE TO FRACTURE, AND ONE (1) KNEE DUE TO PATELLA MALTRACKING. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE RE- REVISIONS. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE LEGION HK TOTAL 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 RISK REDUCTION MEASURES INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR INDUSTRY REPORTS FOR THE LEGION HK KNEE SYSTEM USED IN PRIMARY AND REVISION TKA WERE REVIEWED. ACROSS 7 YEARS OF FOLLOW-UP, THE MEAN KAPLAN-MEIER SURVIVORSHIP FOR THE LEGION HK TOTAL KNEE SYSTEM USED IN PRIMARY TKA IS SIGNIFICANTLY HIGHER THAN THE AOANJRR TKA CLASS BASED ON HIGHER MEAN VALUES AND ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. HOWEVER, IN COMPARISON OF CUMULATIVE REVISION RATES FOR THE LEGION HK KNEE SYSTEM TO THE CLASS OF ALL HINGED DEVICES USED IN PRIMARY TKA IN AUSTRALIA, AS REPORTED IN THE 2024 AOANJRR ANNUAL REPORT, THE LEGION HK TOTAL KNEE IS PERFORMING IN LINE WITH THE CLASS AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. SURVIVAL RATE OF THE LEGION HK SYSTEM MAY BE LOWER THAN ALL OTHER PRIMARY TKA PROCEDURES BECAUSE THIS SYSTEM IS OFTEN USED IN COMPLEX PRIMARY TKA PROCEDURES (E.G. SITUATIONS OF POST-TRAUMATIC ARTHRITIS OR INSUFFICIENT COLLATERAL LIGAMENTS) WHICH MAY MORE LIKELY BE SUBSEQUENTLY REVISED. FOR LEGION HK KNEE SYSTEM USED IN REVISION TKA, THE MEAN KAPLAN-MEIER RE-REVISION RATES WERE IN LINE WITH THE AOANJRR REVISION TKA CLASS ACROSS 6 YEARS OF FOLLOW UP BASED ON THE OVERLAPPING CONFIDENCE INTERVALS, WHICH WERE WIDE DUE TO THE LOW NUMBER OF RECORDED IMPLANTATIONS. IT SHOULD BE NOTED THAT NEITHER THE AOANJRR INDUSTRY REPORTS NOR THE AOANJRR ANNUAL REPORT SPECIFY CUMULATIVE RE-REVISION RATES FOR ALL HINGED DEVICES USED IN REVISION TKAS. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE 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-2025-00279546-1-L1, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 3 RIGHT,71421363, ,71421363, ,00885556414958,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L2, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 RIGHT,71421365, ,71421365, ,00885556414934,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L3, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 RIGHT,71421365, ,71421365, ,00885556414934,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L4, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 RIGHT,71421367, ,71421367, ,00885556414927,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L5, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 RIGHT,71421367, ,71421367, ,00885556414927,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L6, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 RIGHT,71421367, ,71421367, ,00885556414927,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L7, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 4 LEFT,71421374, ,71421374, ,00885556414903,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L8, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L9, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L10, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L11, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L12, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L13, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 LEFT,71421377, ,71421377, ,00885556414880,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L14, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 LEFT,71421377, ,71421377, ,00885556414880,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L15, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 LEFT,71421377, ,71421377, ,00885556414880,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279546-1-L16, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 LEFT,71421377, ,71421377, ,00885556414880,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred thirty-two (232) knees underwent primary TKA procedures between 02-Apr-2015 and 27-Feb-2025, using Legion HK Total Knee system. From these, sixteen (16) knees were later revised due to the following reasons: ten (10) knees due to infection, two (2) knees due to instability, two (2) knees due to fracture, one (1) knee due to malalignment, and one (1) knee due to lysis. ;Timeframe of Registry data: Implantations conducted between 02-Apr-2015 and 27-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 hundred thirty-two (232) primary TKA procedures with Legion HK Total Knee system have been performed in Australia between 02-Apr-2015 and 27-Feb-2025. The cumulative revision rates for these components across 7 years of follow-up, is significantly higher than all TKA class based on higher mean values and on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 3.5% (1.8%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class. ;;-At 2nd postoperative year: 5.4% (3.1%¿9.3%) vs 1.8% (1.8%¿1.9%) of the class. ;;-At 3rd postoperative year: 6.1% (3.5%¿10.3%) vs 2.4% (2.4%¿2.5%) of the class. ;;-At 4th postoperative year: 6.1% (3.5%¿10.3%) vs 2.9% (2.8%¿2.9%) of the class. ;;-At 5th postoperative year: 6.9% (4.1%¿11.4%) vs 3.2% (3.2%¿3.2%) of the class. ;;-At 6th postoperative year: 9.0% (5.4%¿14.7%) vs 3.5% (3.5%¿3.6%) of the class. ;;-At 7th postoperative year: 9.0% (5.4%¿14.7%) vs 3.8% (3.8%¿3.9%) of the class. ;;In comparison of cumulative revision rates for the Legion Total Knee to the class of all hinged devices used in primary TKA, as reported in the AOANJRR 2024 Annual Report, the Legion HK Total Knee is performing in line with the class as shown by overlapping confidence intervals (At 5 follow-up years: 11.2 with a lower 95% confidence interval of 9.9 and a upper 95% confidence interval of 12.6 for the hinged class). It is expected that the survival rate of the Legion HK may be lower than all other primary TKA procedures because the Legion HK Knee System is often used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments,) which may more likely be subsequently revised. This is shown by the indication distribution for the Legion HK system in primary TKA in comparison to the AOANJRR class, as described below: ;;-Osteoarthritis: 84.9% of the total primary TKA procedures with Legion HK vs 97.9% of the AOANJRR Other Total Knee class. ;;-Rheumatoid Arthritis: 5.2% of the total primary TKA procedures with Legion HK vs 1.1% of the AOANJRR Other Total Knee class. ;;-Other Inflammatory Arthritis: 3.0% of the total primary TKA procedures with Legion HK vs 0.5% of the AOANJRR Other Total Knee class. ;;-Osteonecrosis: 0.4% of the total primary TKA procedures with Legion HK vs 0.3% of the AOANJRR Other Total Knee class. ;;-Tumour: 0.4% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Fracture: 4.7% of the total primary TKA procedures with Legion HK vs 0.1% of the AOANJRR Other Total Knee class. ;;-Other: 1.3% of the total primary TKA procedures with Legion HK vs 0.0% of the AOANJRR Other Total Knee class. ;;Further, this is supported by data from the 2024 Annual report which demonstrates higher cumulative revision rates for the class of hinged devices compared to the class of fully stabilized devices used in primary TKA. ;;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, ,0;CASE-2025-00279547-1-L1, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 RIGHT,71421365, ,71421365, ,00885556414934,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L2, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 RIGHT,71421365, ,71421365, ,00885556414934,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L3, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 RIGHT,71421367, ,71421367, ,00885556414927,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L4, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 RIGHT,71421367, ,71421367, ,00885556414927,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L5, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 RIGHT,71421367, ,71421367, ,00885556414927,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L6, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L7, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L8, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L9, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L10, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 LEFT,71421375, ,71421375, ,00885556414897,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279547-1-L11, ,10/14/2025,5/22/2025,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 LEFT,71421377, ,71421377, ,00885556414880,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons. It should be noted that, due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 2 (April 1 - June 30, 2025) ;;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred sixty-four (164) knees underwent revision TKA procedures between 10-Apr-2015 and 21-Nov-2024, using Legion HK Total Knee system. From these, eleven (11) knees were later re-revised due to the following reasons: three (3) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. ;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 21-Nov-2024 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 risk reduction measures 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 one hundred sixty-four (164) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 21-Nov-2024. The cumulative re-revision rates for these components across 6 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 2.5% (0.9%¿6.5%) vs 4.6% (4.2%¿5.0%) of the class. ;;-At 2nd postoperative year: 3.2% (1.3%¿7.4%) vs 8.0% (7.5%¿8.5%) of the class. ;;-At 3rd postoperative year: 6.4% (3.3%¿11.9%) vs 10.6% (10.0%¿11.1%) of the class. ;;-At 4th postoperative year: 7.3% (3.9%¿13.2%) vs 12.6% (11.9%¿13.2%) of the class. ;;-At 5th postoperative year: 8.4% (4.7%¿14.8%) vs 14.3% (13.6%¿15.0%) of the class. ;;-At 6th postoperative year: 8.4% (4.7%¿14.8%) vs 15.5% (14.8%¿16.2%) of the class. ;;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, ,0;CASE-2025-00279546-1-L17,,4/30/2026,3/2/2026,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 5 RIGHT,71421365, ,71421365, ,00885556414934,K081111, ,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of two hundred and fifty-two (252) knees underwent primary TKA procedures between 02-Apr-2015 and 26-Nov-2025, using Legion HK Total Knee system. From these, one (1) patient required a revision surgery due to unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and fifty-two (252) knees underwent primary TKA in which a Legion HK Total Knee System was implanted. Of these, seventeen (17) knees required revision due to the following reasons: nine (9) knees due to infection, two (2) due to instability, two (2) due to fracture, one (1) due to malalignment, one (1) due to lysis, one (1) due to incorrect sizing, one (1) due to implant breakage tibial insert.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;;Timeframe of Registry Data: Implantations conducted between 02-Apr-2015 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 hundred and fifty-two (252) knees underwent primary TKA in which a Legion HK Total Knee System was implanted in Australia between 02-Apr-2015 and 26-Nov-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 3.7% (1.9%¿6.9%) vs 1.0% (1.0%¿1.0%) of the class.;-At 2nd post-operative year: 5.0% (2.9%¿8.7%) vs 1.8% (1.8%¿1.9%) of the class.;-At 3rd post-operative year: 6.1% (3.7%¿10.2%) vs 2.4% (2.4%¿2.4%) of the class.;-At 4th post-operative year: 6.1% (3.7%¿10.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th post-operative year: 6.9% (4.1%¿11.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th post-operative year: 8.7% (5.3%¿13.9%) vs 3.5% (3.5%¿3.5%) of the class.;-At 7th post-operative year: 8.7% (5.3%¿13.9%) vs 3.8% (3.8%¿3.8%) of the class.;;Across post-operative Years 1 through 7, the cumulative revision rates for Legion HK/Legion HK Primary Total Knee Replacement are statistically significantly higher than those of the TKA class. At each evaluated time point, the 95% confidence intervals do not overlap between Legion HK Total Knee System and the class comparator, indicating a statistically significant difference in cumulative revision rates over the assessed follow-up period. However, in comparison of cumulative revision rates for the Legion HK Total Knee System to the class of all hinged devices used in primary TKA, as reported in the 2025 Annual Report:;¿ At 1st post-operative year: 3.7% (1.9%¿6.9%) vs 3.0% (2.4%¿3.9%) of the Hinged TKA class.;¿ At 3rd post-operative year: 6.1% (3.7%¿10.2%) vs 6.3% (5.3%¿7.6%) of the Hinged TKA class.;¿ At 5th post-operative year: 6.9% (4.1%¿11.2%) vs 8.2% (6.9%¿9.7%) of the Hinged TKA class;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, ,0;CASE-2025-00279547-1-L12,,4/30/2026,3/2/2026,Legion HK Total Knee system,LEGION HINGE FEMORAL ASSEMBLY SIZE 7 LEFT,71421377, ,71421377,,00885556414880,K081111,,IN,"It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred seventy?nine (179) knees underwent revision TKA procedures between 10-Apr-2015 and 15-Oct-2025, using Legion HK Total Knee system. From these, one (1) patient required a re-revision surgery due to unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred seventy nine (179) knees underwent revision TKA procedures between 10-Apr-2015 and 15-Oct-2025, using Legion HK Total Knee system. From these, twelve (12) knees were later re-revised due to the following reasons: four (4) knees due to loosening, five (5) knees due to infection, one (1) knee due to pain, one (1) knee due to fracture, and one (1) knee due to patella maltracking. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 10-Apr-2015 and 15-Oct-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Total 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 one hundred seventy nine (179) revision TKA procedures with Legion HK Total Knee system have been performed in Australia between 10-Apr-2015 and 15-Oct-2025. The cumulative re-revision rates for these components across 7 years of follow-up available were in line with the TKA revision class, based on the overlapping confidence intervals. Confidence intervals were wide due to the low number of recorded implantations. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (0.9%¿6.1%) vs 4.0% (3.6%¿4.4%) of the class.;-At 2nd postoperative year:3.0% (1.2%¿7.0%) vs 7.1% (6.6%¿7.6%) of the class.;-At 3rd postoperative year:6.7% (3.6%¿12.1%) vs 9.5% (9.0%¿10.1%) of the class.;-At 4th postoperative year:7.5% (4.2%¿13.2%) vs 11.4% (10.8%¿12.1%) of the class.;-At 5th postoperative year:8.5% (4.9%¿14.6%) vs 13.1% (12.4%¿13.8%) of the class.;-At 6th postoperative year:8.5% (4.9%¿14.6%) vs 14.1% (13.4%¿14.9%) of the class.;-At 7th postoperative year:8.5% (4.9%¿14.6%) vs 15.0% (14.2%¿15.8%) of the class.;;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, ,0;
BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF LEGION HK TOTAL KNEE SYSTEM IN PRIMARY AND REVISION TKA SURGERIES. PRIMARY TKA PROCEDURES. A TOTAL OF TWO HUNDRED THIRTY-TWO (232) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN 02-APR-2015 AND 27-FEB-2025, USING LEGION HK TOTAL KNEE SYSTEM. FROM THESE, SIXTEEN (16) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TEN (10) KNEES DUE TO INFECTION, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO FRACTURE, ONE (1) KNEE DUE TO MALALIGNMENT, AND ONE (1) KNEE DUE TO LYSIS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE REVISIONS. REVISION TKA PROCEDURES. A TOTAL OF ONE HUNDRED SIXTY-FOUR (164) KNEES UNDERWENT REVISION TKA PROCEDURES BETWEEN 10-APR-2015 AND 21-NOV-2024, USING LEGION HK TOTAL KNEE SYSTEM. FROM THESE, ELEVEN (11) KNEES WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: THREE (3) KNEES DUE TO LOOSENING, FIVE (5) KNEES DUE TO INFECTION, ONE (1) KNEE DUE TO PAIN, ONE (1) KNEE DUE TO FRACTURE, AND ONE (1) KNEE DUE TO PATELLA MALTRACKING. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE RE-REVISIONS. ALTOGETHER, A TOTAL QUANTITY OF 16 REVISIONS AND 11 RE-REVISIONS (27 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AOANJRR FOR THE LEGION HK TOTAL KNEE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121895 | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | KRO | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Unknown |