LEGION HK HINGE KNEE SYSTEM
Report
- Report Number
- 1020279-2025-00479
- Event Type
- Injury
- Date Received
- March 15, 2025
- Report Date
- October 17, 2025
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- KRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTED DATA: NUMBER ASSIGNED TO 'LAST LINE-ITEM VERSION' FOR THE FOLLOWING COMPLAINT HAS BEEN UPDATED FROM VERSION "1" TO VERSION "0": -(B)(4). THIS CHANGE REFLECTS THAT THESE ARE NEW ENTRIES NOT PREVIOUSLY REPORTED IN THE INITIAL 3500A FORM + .CSV SPREADSHEET SUBMISSION DATED MARCH 14, 2025. AS SUCH, THESE NEW LINE ITEMS SHOULD HAVE BEEN DENOTED AS VERSION "0". THESE UPDATES WERE MADE IN RESPONSE TO THE FDA'S CLARIFICATION ON OCTOBER 16, 2025, REGARDING THE CORRECT USE OF VERSION 0, VERSION 1 AND VERSION 2 IN THE 'LATEST LINE-ITEM VERSION' COLUMN OF THE .CSV FILE ATTACHED TO THE SUBMISSION. NO ADDITIONAL CHANGES HAVE BEEN MADE TO THE 3500A FORM OR TO THE INFORMATION PROVIDED IN THE OTHER COLUMNS OF THE.CSV SPREADSHEET PREVIOUSLY SUBMITTED ON OCTOBER 12, 2025.
REPORTING QUARTER: 1 ((B)(6)2025). SUMMARY OF ADVERSE EVENTS: IT WAS REPORTED THAT, IN THE AMERICAN JOINT REPLACEMENT REGISTRY (AJRR) FROM THE UNITED STATES, A TOTAL OF TWO HUNDRED FORTY-FOUR (244) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN (B)(6)2012 AND (B)(6)2024, USING A LEGION HK HINGE KNEE SYSTEM. FROM THESE, TWENTY-TWO KNEES (22) WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURES, THIRTEEN (13) KNEES DUE TO INFECTIONS, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO MECHANICAL LOOSENING, ONE (1) KNEE DUE TO OTHER UNSPECIFIED MECHANICAL COMPLICATIONS, THREE (3) KNEES DUE TO PAIN, AND SEVEN (7) KNEES DUE TO OTHER UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN (B)(6)2012 AND (B)(6)2024 IN THE UNITED STATES. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE LEGION HK HINGED KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT OF THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND RISK REDUCTION MEASURES INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF TWO HUNDRED FORTY-FOUR (244) PRIMARY TKA PROCEDURES WITH THE LEGION HK HINGE KNEE SYSTEM HAVE BEEN PERFORMED IN THE UNITED STATES BETWEEN (B)(6)2012 AND (B)(6)2024. THE CUMULATIVE REVISION RATES FOR THIS COMBINATION ARE CONSISTENTLY HIGHER THAN THE REVISION RATES PROVIDED FOR THE AJRR TKA AGGREGATE (REFERRED TO AS ¿THE CLASS¿ BELOW) FROM THE FIRST THROUGH THE TENTH POSTOPERATIVE YEAR. THIS DIFFERENCE IS STATISTICALLY SIGNIFICANT BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. THE FOLLOWING CUMULATIVE REVISION RATES WITH (B)(4) CONFIDENCE INTERVALS ARE PRESENTED IN THIS REPORT: O AT 1ST POSTOPERATIVE YEAR: 4.16% (2.45%-5.84%) VS 0.99% (0.98%-1.0%) OF THE CLASS. O AT 2ND POSTOPERATIVE YEAR: 6.42% (3.80%-8.96%) VS 1.54% (1.53%-1.56%) OF THE CLASS. O AT 3RD POSTOPERATIVE YEAR: 7.95% (4.73%-11.06%) VS 1.92% (1.9%-1.94%) OF THE CLASS. O AT 4TH POSTOPERATIVE YEAR: 9.17% (5.47%-12.72%) VS 2.23% (2.2%-2.25%) OF THE CLASS. O AT 5TH POSTOPERATIVE YEAR: 10.19% (6.09%-14.10%) VS 2.49% (2.47%-2.51%) OF THE CLASS. O AT 6TH POSTOPERATIVE YEAR: 11.08% (6.64%-15.31%) VS 2.72% (2.69%-2.75%) OF THE CLASS. O AT 7TH POSTOPERATIVE YEAR: 11.87% (7.13%-16.37%) VS 2.92% (2.89%-2.95%) OF THE CLASS. O AT 8TH POSTOPERATIVE YEAR: 12.06% (7.58%-17.34%) VS 3.11% (3.08%-3.14%) OF THE CLASS. O AT 9TH POSTOPERATIVE YEAR: 13.23% (7.98%-18.19%) VS 3.28% (3.25%-3.31%) OF THE CLASS. O AT 10TH POSTOPERATIVE YEAR: 13.74% (8.29%-18.87%) VS 3.41% (3.38%-3.45%) OF THE CLASS. THIS SYSTEM IS USED IN COMPLEX PRIMARY TKA PROCEDURES (E.G. SITUATIONS OF POST-TRAUMATIC ARTHRITIS OR INSUFFICIENT COLLATERAL LIGAMENTS) AND IN REVISION SURGERIES, ALTHOUGH IT IS PRIMARILY USED IN REVISION SURGERIES (TOTAL N IN PRIMARY TKAS = 244 VS 578 IN REVISION SURGERIES). HOWEVER, THE AGGREGATE CLASS CONTAINS ALSO SYSTEMS USED FAR LESS OFTEN FOR COMPLEX PRIMARY PROCEDURES. AS DENOTED BY THE REGISTRY PERSONNEL, THE OBSERVED PERFORMANCE IS NOT UNUSUAL WHEN COMPARING SYSTEMS INTENDED FOR REVISION AND COMPLEX SURGERIES WITH THE PRIMARY POPULATION. ALSO, AS THE PATIENT POPULATION IS CONSIDERABLY SMALLER COMPARED TO THE AGGREGATE KNEE CLASS, WHICH CAN INFLATE THE REVISION RATE. FURTHER REVIEW OF DATA EXTRACTED FROM OTHER REGISTRIES LIKE THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION JOINT REPLACEMENT REGISTRY (AOANJRR) 2024 ANNUAL REPORT INDICATES THAT THE LEGION HK HINGE SYSTEM IS PERFORMING SIMILAR TO OTHER HINGED KNEES AT 1, 3, 5 AND 10 POSTOPERATIVE YEARS DUE TO OVERLAPPING OF CONFIDENCE INTERVALS. ALTHOUGH THE NATIONAL JOINT REGISTRY (NJREW) FROM THE UNITED KINGDOM DOES NOT PROVIDE REVISION INFORMATION FOR PRIMARY PROCEDURES USING LEGION HK HINGE KNEE SYSTEMS, A QUARTERLY SUMMARY REPORT AVAILABLE FROM (B)(6) 2021 INDICATES THAT THIS SYSTEM HAS A COMPARABLE CUMULATIVE REVISION RATE COMPARED TO THE NJREW CLASS AVERAGE FOR ALL OTHER HINGED KNEES UP TO 4 YEARS BASED ON OVERLAPPING CONFIDENCE INTERVALS. A SIMILAR CONCLUSION IS DRAWN FROM THE OBSERVED REVISION RATES IN THE GERMAN ARTHROPLASTY REGISTER (EPRD) UP TO 5 POSTOPERATIVE YEARS. A HIGH PROPORTION OF THE COMPLICATIONS REPORTED WERE ASSOCIATED TO INFECTED KNEES (13/22), WHICH IS LIKELY NOT DEVICE RELATED BUT COULD BE A RESULT OF THE SURGICAL TECHNIQUE. THE INFECTIONS COULD ALSO BE DUE TO IMPLANTATION INTO A PATIENT WITH A PRIOR INFECTION, AN INFECTION ACQUIRED FROM AN OPEN FRACTURE, OR HEMATOGENOUSLY SPREAD. OTHER FACTORS SUCH AS PATIENT COMORBIDITIES AND HINGED IMPLANTS REQUIRING PROLONGED SURGERY TIMES WITH MORE SOFT TISSUE EXPOSURE AND TRAUMA MAY INCREASE THE RISK OF INFECTION. 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.
CORRECTED DATA: A2 (MEAN AGE OF PATIENTS UPDATED TO 66), B5 (NARRATIVE UPDATED TO INCORPORATE ADDITIONAL EVENTS), H2 (NUMBER OF SUMMARIZED EVENTS UPDATED TO 65), H6 (ADDITIONAL CODES ADDED FOR 'HEALTH EFFECT - CLINICAL CODE' AND 'MEDICAL DEVICE PROBLEM CODE' PERTAINING TO THE ADDITIONAL EVENTS INCORPORATED TO THIS 3500A FORM SUBMISSION). H11: THIS REPORT IS SUBMITTED IN RESPONSE TO THE FDA¿S OBSERVATIONS REGARDING SMITH+NEPHEW¿S (S+N) SUMMARY MDR REPORTING PRACTICES UNDER RWD(B)(4), COMMUNICATED ON (B)(6) 2025. AS A RESULT, THE MDR WITH REFERENCE 1020279-2025-00479 INCORPORATES ALL THE REAL WORD DATA SHARING THE FOLLOWING BUNDLING CRITERIA: REGISTRATION NUMBER: 1020279, DATA SOURCE: AMERICAN JOINT REPLACEMENT REGISTRY (AJRR), REPORT TYPE: SERIOUS INJURY, PRODUCT CLASSIFICATION CODE: KRO. ADDITIONAL COMPLAINTS HAVE BEEN ADDED SINCE THE PREVIOUS SUBMISSION ON (B)(6) 2025: (B)(4) (L1-L43). EXCEPT FOR THE CORRECTED FIELDS NOTED ABOVE UNDER 'CORRECTED DATA,' THE INFORMATION PROVIDED IN THE REQUIRED FIELDS OF THE PRIOR 3500A FORM SUBMITTED ON (B)(6) 2025 REMAINS UNCHANGED. REPORTING QUARTER: 1 ((B)(6) 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AMERICAN JOINT REPLACEMENT REGISTRY (AJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED STATES FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - LEGION HINGED KNEE (HK) DEVICES (TIBIAL OR FEMORAL): IMPLANTED IN TWO HUNDRED FORTY-FOUR (244) KNEES BETWEEN (B)(6) 2012 AND (B)(6) 2024. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWENTY-TWO (22) CASES DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURES, THIRTEEN (13) KNEES DUE TO INFECTIONS, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO MECHANICAL LOOSENING, ONE (1) KNEE DUE TO OTHER UNSPECIFIED MECHANICAL COMPLICATIONS, THREE (3) KNEES DUE TO PAIN, AND SEVEN (7) KNEES DUE TO OTHER UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE ASSOCIATED WITH A SINGLE REVISION SURGERY. THE STRUCTURE OF THE AJRR REPORT DOES NOT ALLOW S+N TO DISTINCTLY MATCH SPECIFIC REASON(S) FOR REVISION TO A SINGLE EVENT. 2. REVISION TKA PROCEDURES: - LEGION HINGED KNEE (HK) DEVICES (TIBIAL OR FEMORAL): IMPLANTED IN FIVE HUNDRED SEVENTY-EIGHT (578) KNEES BETWEEN (B)(6) 2012 AND (B)(6) 2024. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN FORTY-THREE (43) CASES DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) KNEES DUE TO PERIPROSTHETIC FRACTURE, EIGHTEEN (18) KNEES DUE TO INFECTION, EIGHT (8) KNEES DUE TO INSTABILITY, TWELVE (12) KNEES DUE TO MECHANICAL LOOSENING, NINE (9) KNEES DUE TO OTHER UNSPECIFIED MECHANICAL COMPLICATIONS, TWO (2) KNEES DUE TO WEAR OR OSTEOLYSIS, ONE (1) KNEE DUE TO HEMATOMA OR WOUND COMPLICATIONS, THREE (3) KNEES DUE TO PAIN, ONE (1) KNEE DUE TO STIFFNESS AND TWO (2) KNEES DUE TO UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE ASSOCIATED WITH A SINGLE REVISION SURGERY. THE STRUCTURE OF THE AJRR REPORT DOES NOT ALLOW S+N TO DISTINCTLY MATCH SPECIFIC REASON(S) FOR REVISION TO A SINGLE EVENT. ALTOGETHER, A TOTAL QUANTITY OF 22 REVISIONS AND 43 RE-REVISIONS (65 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AJRR FOR THE LEGION HINGED KNEE SYSTEM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE LEGION HINGED 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. MANUFACTURERS JOINT REGISTRY REPORTS FOR THE LEGION HK COMPONENTS PROVIDED DATA USAGE IN PRIMARY AND REVISION TKA. FOR LEGION HK COMPONENTS USED IN PRIMARY TKA PROCEDURES, THE CUMULATIVE REVISION RATES ARE CONSISTENTLY HIGHER THAN THE REVISION RATES PROVIDED FOR THE AJRR TKA AGGREGATE FROM THE FIRST THROUGH THE TENTH POSTOPERATIVE YEAR. THE AJRR REPORTS THAT WHEN REVISION DEVICES (SUCH AS THE LEGION HK) ARE USED IN PRIMARY POPULATION, THEY ALWAYS SEEM TO PERFORM WORSE COMPARED TO THE AGGREGATE GROUP, AND THAT IT APPEARS TO BE CONSISTENT ACROSS DIFFERENT DEVICES. MOREOVER, HINGE DEVICES ARE USED IN MORE COMPLEX PRIMARY IMPLANTATIONS, THUS ARE NOT DIRECTLY COMPARABLE TO THE TOTAL TKA CLASS. MOST APPROPRIATE COMPARATOR WOULD BE THE HINGED CLASS WHICH IS HOWEVER NOT AVAILABLE IN THE REPORT. IN ADDITION, 59% OF THE SUBJECT DEVICE REVISIONS WERE DUE TO INFECTION, WHICH IS NOT DIRECTLY RELATED TO DEVICE PERFORMANCE. FOR LEGION HK COMPONENTS USED IN REVISION TKA PROCEDURES, THE MEAN CUMULATIVE RE-REVISION RATES ARE LOWER THAN THE AJRR TKA RE-REVISION AGGREGATE AT ALL AVAILABLE FOLLOW UP YEARS. THIS INDICATES THAT THE SUBJECT DEVICE PERFORMS IN LINE WITH THE CLASS. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE AND PROCEDURE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.
Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00256041-1-L1,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L2,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L3,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L4,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L5,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L6,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L7,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L8,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L9,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L10,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L11,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L12,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L13,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L14,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L15,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L16,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L17,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L18,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L19,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L20,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L21,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256041-1-L22,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred forty-four (244) knees underwent primary TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, twenty-two knees (22) were later revised due to the following complications: three (3) knees due to periprosthetic fractures, thirteen (13) knees due to infections, two (2) knees due to instability, two (2) knees due to mechanical loosening, one (1) knee due to other unspecified mechanical complications, three (3) knees due to pain, and seven (7) knees due to other unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two hundred forty-four (244) primary TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are consistently higher than the revision rates provided for the AJRR TKA aggregate (referred to as ¿the class¿ below) from the first through the tenth postoperative year. This difference is statistically significant based on the non-overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.16% (2.45%-5.84%) vs 0.99% (0.98%-1.0%) of the class.;o At 2nd postoperative year: 6.42% (3.80%-8.96%) vs 1.54% (1.53%-1.56%) of the class.;o At 3rd postoperative year: 7.95% (4.73%-11.06%) vs 1.92% (1.9%-1.94%) of the class.;o At 4th postoperative year: 9.17% (5.47%-12.72%) vs 2.23% (2.2%-2.25%) of the class.;o At 5th postoperative year: 10.19% (6.09%-14.10%) vs 2.49% (2.47%-2.51%) of the class.;o At 6th postoperative year: 11.08% (6.64%-15.31%) vs 2.72% (2.69%-2.75%) of the class.;o At 7th postoperative year: 11.87% (7.13%-16.37%) vs 2.92% (2.89%-2.95%) of the class.;o At 8th postoperative year: 12.06% (7.58%-17.34%) vs 3.11% (3.08%-3.14%) of the class.;o At 9th postoperative year: 13.23% (7.98%-18.19%) vs 3.28% (3.25%-3.31%) of the class.;o At 10th postoperative year: 13.74% (8.29%-18.87%) vs 3.41% (3.38%-3.45%) of the class.;;;This system is used in complex primary TKA procedures (e.g. situations of post-traumatic arthritis or insufficient collateral ligaments) and in revision surgeries, although it is primarily used in revision surgeries (total n in primary TKAs = 244 vs 578 in revision surgeries). However, the aggregate class contains also systems used far less often for complex primary procedures. As denoted by the registry personnel, the observed performance is not unusual when comparing systems intended for revision and complex surgeries with the primary population. Also, as the patient population is considerably smaller compared to the aggregate knee class, which can inflate the revision rate.;;Further review of data extracted from other registries like the Australian Orthopaedic Association Joint Replacement Registry (AOANJRR) 2024 annual report indicates that the Legion HK Hinge System is performing similar to other Hinged Knees at 1, 3, 5 and 10 postoperative years due to overlapping of confidence intervals. Although the National Joint Registry (NJREW) from the United Kingdom does not provide revision information for primary procedures using Legion HK Hinge Knee Systems, a quarterly summary report available from May 2021 indicates that this system has a comparable cumulative revision rate compared to the NJREW class average for all other hinged knees up to 4 years based on overlapping confidence intervals. A similar conclusion is drawn from the observed revision rates in the German Arthroplasty Register (EPRD) up to 5 postoperative years. ;;A high proportion of the complications reported were associated to infected knees (13/22), which is likely not device related but could be a result of the surgical technique. The infections could also be due to implantation into a patient with a prior infection, an infection acquired from an open fracture, or hematogenously spread. Other factors such as patient comorbidities and hinged implants requiring prolonged surgery times with more soft tissue exposure and trauma may increase the risk of infection.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00256050-1-L1,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L2,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L3,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L4,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L5,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L6,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L7,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L8,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L9,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L10,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L11,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L12,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L13,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L14,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L15,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L16,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L17,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L18,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L19,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L20,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L21,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L22,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L23,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L24,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L25,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L26,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L27,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L28,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L29,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L30,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L31,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L32,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L33,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L34,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L35,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L36,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L37,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L38,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L39,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L40,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L41,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L42,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00256050-1-L43,,10/12/2025,1/31/2025,LEGION HK Hinge Knee System,LEGION HK Hinge Knee System,,,,,,K081111,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, one (1) knee was re-revised due to unknown complications. Based on the stratification used by the AJRR, no specific reason(s) for revision can be definitively linked to the revision surgery referenced through this line item.","Reporting Quarter: 1 (January 1 - March 31, 2025);;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five hundred seventy-eight (578) knees underwent revision TKA procedures between 01-Sep-2012 and 30-Sep-2024, using a Legion HK Hinge Knee system. From these, forty-three knees (43) were later re-revised due to the following complications: two (2) knees due to periprosthetic fracture, eighteen (18) knees due to infection, eight (8) knees due to instability, twelve (12) knees due to mechanical loosening, nine (9) knees due to other unspecified mechanical complications, two (2) knees due to wear or osteolysis, one (1) knee due to hematoma or wound complications, three (3) knees due to pain, one (1) knee due to stiffness and two (2) knees due to unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;Timeframe of Registry data: Implantations conducted between 01-Sep-2012 and 30-Sep-2024 in the United States.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Legion HK Hinged Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of five hundred seventy-eight (578) revision TKA procedures with the Legion HK Hinge Knee system have been performed in the United States between 01-Sep-2012 and 30-Sep-2024. The cumulative revision rates for this combination are lower than the revision rates provided for the AJRR aggregate TKA revisions (referred to as ¿the class¿ below) from the first through the twelfth postoperative year. This difference is non-significant based on the overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 5.24% (3.70%-6.75%) vs 6.19% (6.07%-6.31%) of the class.;o At 2nd postoperative year: 6.93% (4.91%-8.91%) vs 8.17% (8.04%-8.31%) of the class.;o At 3rd postoperative year: 7.95% (5.65%-10.20%) vs 9.36%% (9.21%-9.51%) of the class.;o At 4th postoperative year: 8.69% (6.18%-11.14%) vs 10.23% (10.07%-10.39%) of the class.;o At 5th postoperative year: 9.26% (6.59%-11.85%) vs 10.89% (10.72%-11.05%) of the class.;o At 6th postoperative year: 9.66% (6.88%-12.36%) vs 11.36% (11.18%-11.53%) of the class.;o At 7th postoperative year: 10.01% (7.13%-12.79%) vs 11.76% (11.57%-11.94%) of the class.;o At 8th postoperative year: 10.26% (7.32%-13.11%) vs 12.06% (11.86%-12.25%) of the class.;o At 9th postoperative year: 10.44% (7.45%-13.34%) vs 12.27% (12.07%-12.47%) of the class.;o At 10th postoperative year: 10.67% (7.61%-13.63%) vs 12.53% (12.32%-12.75%) of the class.;o At 11th postoperative year: 10.99% (7.84%-14.03%) vs 12.90% (12.63%-13.16%) of the class.;o At 12th postoperative year: 11.20% (7.99%-14.30%) vs 13.14% (12.82%-13.47%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;
IT WAS REPORTED THAT, IN THE AMERICAN JOINT REPLACEMENT REGISTRY (AJRR) FROM THE UNITED STATES, A TOTAL OF TWO HUNDRED FORTY-FOUR (244) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN (B)(6)2012 AND (B)(6)2024, USING A LEGION HK HINGE KNEE SYSTEM. FROM THESE, TWENTY-TWO KNEES (22) WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURES, THIRTEEN (13) KNEES DUE TO INFECTIONS, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO MECHANICAL LOOSENING, ONE (1) KNEE DUE TO OTHER UNSPECIFIED MECHANICAL COMPLICATIONS, THREE (3) KNEES DUE TO PAIN, AND SEVEN (7) KNEES DUE TO OTHER UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN (B)(6)2012 AND (B)(6)2024 IN THE UNITED STATES.
BASED ON REAL WORLD DATA FROM THE AMERICAN JOINT REPLACEMENT REGISTRY (AJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED STATES FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - LEGION HINGED KNEE (HK) DEVICES (TIBIAL OR FEMORAL): IMPLANTED IN TWO HUNDRED FORTY-FOUR (244) KNEES BETWEEN (B)(6) 2012 AND (B)(6) 2024. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWENTY-TWO (22) CASES DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURES, THIRTEEN (13) KNEES DUE TO INFECTIONS, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO MECHANICAL LOOSENING, ONE (1) KNEE DUE TO OTHER UNSPECIFIED MECHANICAL COMPLICATIONS, THREE (3) KNEES DUE TO PAIN, AND SEVEN (7) KNEES DUE TO OTHER UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE ASSOCIATED WITH A SINGLE REVISION SURGERY. THE STRUCTURE OF THE AJRR REPORT DOES NOT ALLOW S+N TO DISTINCTLY MATCH SPECIFIC REASON(S) FOR REVISION TO A SINGLE EVENT. 2. REVISION TKA PROCEDURES: - LEGION HINGED KNEE (HK) DEVICES (TIBIAL OR FEMORAL): IMPLANTED IN FIVE HUNDRED SEVENTY-EIGHT (578) KNEES BETWEEN (B)(6) 2012 AND (B)(6) 2024. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN FORTY-THREE (43) CASES DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) KNEES DUE TO PERIPROSTHETIC FRACTURE, EIGHTEEN (18) KNEES DUE TO INFECTION, EIGHT (8) KNEES DUE TO INSTABILITY, TWELVE (12) KNEES DUE TO MECHANICAL LOOSENING, NINE (9) KNEES DUE TO OTHER UNSPECIFIED MECHANICAL COMPLICATIONS, TWO (2) KNEES DUE TO WEAR OR OSTEOLYSIS, ONE (1) KNEE DUE TO HEMATOMA OR WOUND COMPLICATIONS, THREE (3) KNEES DUE TO PAIN, ONE (1) KNEE DUE TO STIFFNESS AND TWO (2) KNEES DUE TO UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE ASSOCIATED WITH A SINGLE REVISION SURGERY. THE STRUCTURE OF THE AJRR REPORT DOES NOT ALLOW S+N TO DISTINCTLY MATCH SPECIFIC REASON(S) FOR REVISION TO A SINGLE EVENT. ALTOGETHER, A TOTAL QUANTITY OF 22 REVISIONS AND 43 RE-REVISIONS (65 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AJRR FOR THE LEGION HINGED KNEE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 900438 | LEGION HK HINGE KNEE SYSTEM | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | KRO | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Unknown | Required Intervention |