PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Report

• Report Number: 1020279-2026-00545
• Event Type: Injury
• Date Received: April 23, 2026
• Report Date: April 23, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: KRO
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: GM
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 1 (JANUARY 1 - MARCH 31, 2026). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - LEGION HINGE FEMORAL ASSEMBLY COMPONENTS: IMPLANTED IN EIGHTY-FOUR (84) KNEES BETWEEN 01-MAR-2015 AND 28-FEB-2025. FROM THESE, NINE (9) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: THREE (3) KNEES DUE TO INFECTION, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, AND FIVE (5) KNEES DUE TO OTHER-UNKNOWN REASONS. 2. REVISION TKA PROCEDURES: - LEGION HINGE FEMORAL ASSEMBLY COMPONENTS: IMPLANTED IN TWO HUNDRED SIXTY-EIGHT (268) KNEES BETWEEN 01-AUG-2014 AND 31-MAR-2025. FROM THESE, FORTY-SIX (46) KNEES REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: TWENTY SEVEN (27) KNEES DUE TO INFECTION, TWO (2) KNEES DUE TO DISLOCATION / INSTABILITY, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO ASEPTIC LOOSENING, AND FOURTEEN (14) KNEES DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF NINE (9) REVISIONS AND FORTY-SIX (46) RE-REVISIONS HAVE BEEN REPORTED IN THE EPRD FOR THE LEGION HINGE FEMORAL ASSEMBLY COMPONENTS RESULTING IN A TOTAL OF 55 EVENTS SUMMARIZED THROUGH THIS 3500A FORM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE LEGION HINGE TOTAL KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENTS 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 THEIR 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. EPRD REPORTS THAT FOR THE LEGION HINGE FEMORAL ASSEMBLY COMPONENTS A TOTAL OF EIGHTY-FOUR (84) PRIMARY TKA WERE CAPTURED. THE MEAN CUMULATIVE REVISION RATES WERE IN LINE WITH THE CLASS DEVICE, BASED ON THE OVERLAPPING CONFIDENCE INTERVALS, ACROSS 10 YEARS OF FOLLOW-UP. WIDE CONFIDENCE INTERVALS FOR THE SUBJECT DEVICE ARE AT LEAST IN PART DUE TO THE LOW VOLUME OF RECORDED IMPLANTATIONS. FOR REVISION TKA, A TOTAL OF TWO HUNDRED SIXTY-EIGHT (268) IMPLANTATIONS WERE CAPTURED. THE MEAN CUMULATIVE RE-REVISION RATE WAS IN LINE WITH THE CLASS DEVICE, BASED ON THE OVERLAPPING CONFIDENCE INTERVALS, ACROSS 10 YEARS OF FOLLOW-UP. WIDE CONFIDENCE INTERVALS FOR THE SUBJECT DEVICE ARE AT LEAST IN PART DUE TO THE LOW VOLUME OF RECORDED IMPLANTATIONS. 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.

Description of Event or Problem · 0

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-2026-00315017-1-L1,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L2,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L3,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L4,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to periprosthetic fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L5,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L6,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L7,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L8,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315017-1-L9,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of eighty-four (84) knees underwent primary TKA procedures between 01-Mar-2015 and 28-Feb-2025, using a Legion Hinge femoral assembly component. From these, nine (9) knees were later revised due to the following complications: three (3) knees due to infection, one (1) knee due to periprosthetic fracture, and five (5) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Mar-2015 and 28-Feb-2025 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 eighty-four (84) knees underwent primary TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Mar-2015 and 28-Feb-2025. The mean cumulative revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.9% (2.4%¿15.1%) vs 4.1% (3.9%¿4.4%) of the class.;-At 2nd postoperative year: 8.9% (2.4%¿15.1%) vs 5.6% (5.3%¿5.9%) of the class.;-At 3rd postoperative year: 10.6% (3.3%¿17.4%) vs 6.4% (6.0%¿6.7%) of the class.;-At 4th postoperative year: 10.6% (3.3%¿17.4%) vs 6.8% (6.5%¿7.1%) of the class.;-At 5th postoperative year: 10.6% (3.3%¿17.4%) vs 7.2% (6.9%¿7.6%) of the class.;-At 7th postoperative year: 18.1% (1.1%¿32.1%) vs 8.0% (7.6%¿8.4%) of the class.;-At 9th postoperative year: 18.1% (1.1%¿32.1%) vs 8.7% (8.1%¿9.2%) of the class.;-At 10th postoperative year: 18.1% (1.1%¿32.1%) vs 9.2% (8.4%¿9.9%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L1,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L2,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L3,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L4,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L5,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L6,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L7,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L8,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L9,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L10,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L11,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L12,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L13,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L14,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L15,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L16,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L17,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L18,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L19,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L20,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L21,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L22,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L23,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L24,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L25,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L26,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L27,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L28,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to dislocation / instability.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L29,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to dislocation / instability.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L30,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to periprosthetic fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L31,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to aseptic loosening.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L32,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to aseptic loosening.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L33,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L34,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L35,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L36,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L37,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L38,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L39,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L40,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L41,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L42,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L43,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L44,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L45,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315056-1-L46,,4/23/2026,3/2/2026,Legion Hinge Total Knee System ,Legion Hinge femoral assembly,,,,,,K081111,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, one (1) patient required a re-revision surgery due to other-unknown reasons.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of two hundred sixty-eight (268) knees underwent revision TKA procedures between 01-Aug-2014 and 31-Mar-2025, using a Legion Hinge femoral assembly component. From these, forty six (46) knees were later re-revised due to the following complications: twenty seven (27) knees due to infection, two (2) knees due to dislocation / instability, one (1) knee due to periprosthetic fracture, two (2) knees due to aseptic loosening, and fourteen (14) knees due to other-unknown reasons.;;Timeframe of Registry Data: Implantations conducted between 01-Aug-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion Hinge 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 two hundred sixty-eight (268) knees underwent revision TKA procedures in which a Legion Hinge femoral assembly component was implanted in Germany between 01-Aug-2014 and 31-Mar-2025. The mean cumulative re-revision rates were in line with the class device, based on the overlapping confidence intervals, across 10 years of follow-up. Wide confidence intervals for the subject device are at least in part due to the low volume of recorded implantations.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 8.6% (5.1%¿12.0%) vs 7.3% (7.1%¿7.4%) of the class.;-At 2nd postoperative year: 13.0% (8.6%¿17.3%) vs 11.5% (11.3%¿11.8%) of the class.;-At 3rd postoperative year: 16.9% (11.6%¿21.9%) vs 14.1% (13.8%¿14.4%) of the class.;-At 4th postoperative year: 18.6% (12.9%¿23.9%) vs 16.0% (15.7%¿16.3%) of the class.;-At 5th postoperative year: 22.2% (15.3%¿28.6%) vs 17.4% (17.0%¿17.7%) of the class.;-At 7th postoperative year: 29.7% (18.8%¿39.0%) vs 19.8% (19.4%¿20.2%) of the class.;-At 9th postoperative year: 33.4% (20.4%¿44.2%) vs 21.7% (21.2%¿22.2%) of the class.;-At 10th postoperative year: 33.4% (20.4%¿44.2%) vs 22.8% (22.1%¿23.4%) 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - LEGION HINGE FEMORAL ASSEMBLY COMPONENTS: IMPLANTED IN EIGHTY-FOUR (84) KNEES BETWEEN 01-MAR-2015 AND 28-FEB-2025. FROM THESE, NINE (9) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: THREE (3) KNEES DUE TO INFECTION, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, AND FIVE (5) KNEES DUE TO OTHER-UNKNOWN REASONS. 2. REVISION TKA PROCEDURES: - LEGION HINGE FEMORAL ASSEMBLY COMPONENTS: IMPLANTED IN TWO HUNDRED SIXTY-EIGHT (268) KNEES BETWEEN 01-AUG-2014 AND 31-MAR-2025. FROM THESE, FORTY-SIX (46) KNEES REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: TWENTY-SEVEN (27) KNEES DUE TO INFECTION, TWO (2) KNEES DUE TO DISLOCATION / INSTABILITY, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO ASEPTIC LOOSENING, AND FOURTEEN (14) KNEES DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF NINE (9) REVISIONS AND FORTY-SIX (46) RE-REVISIONS HAVE BEEN REPORTED IN THE EPRD FOR THE LEGION HINGE FEMORAL ASSEMBLY COMPONENTS RESULTING IN A TOTAL OF 55 EVENTS SUMMARIZED THROUGH THIS 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1028576		PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER	KRO	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR	Unknown

Terms

Patient problem · 5

• Aseptic loosening
• Insufficient Information
• Joint Dislocation
• Periprosthetic fracture
• Unspecified Infection

Product problems · 2

• Adverse Event Without Identified Device or Use Problem
• Loosening of Implant Not Related to Bone-Ingrowth

Source type · 1

• Other

Type of report · 1

• Initial submission