BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

    MDR report key: 25051904 · Received April 30, 2026

    Report

    Report Number
    1020279-2026-00586
    Event Type
    Injury
    Date Received
    April 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING QUARTER: 1 (JANUARY 1 - MARCH 31, 2026) SUMMARY OF ADVERSE EVENTS: IT WAS REPORTED THAT, BASED ON THE DATA GATHERED BY THE NATIONAL JOINT REGISTRY (NJR), A TOTAL OF EIGHTY-EIGHT THOUSAND SEVEN HUNDRED THIRTY-SEVEN (88,737) KNEES UNDERWENT PRIMARY TKA BETWEEN (B)(6) 2003 AND (B)(6) 2026, USING A GENESIS II CR COCR FEMORAL COMPONENT. THIS TOTAL INCLUDES FEMORAL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JWH AND MBH. OF THE ONE THOUSAND SEVEN HUNDRED EIGHTY-THREE (1,783) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, TWELVE (12) REVISIONS WERE ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS II CR COCR FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE MBH. OF THESE, TWELVE (12) KNEES REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE (3) KNEES DUE TO INFECTION, TWO (2) KNEES DUE TO ASEPTIC LOOSENING OF THE FEMUR, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO OTHER REASONS, TWO (2) KNEES DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO UNEXPLAINED PAIN, AND ONE (1) KNEE DUE TO STIFFNESS, ONE (1) KNEE DUE TO ASEPTIC LOOSENING OF THE TIBIA, ONE (1) KNEE DUE TO TIBIAL LYSIS, AND ONE (1) KNEE DUE TO POLYETHYLENE COMPONENT WEAR. MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE REVISION CASE. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED BY THE NATIONAL JOINT REGISTRY (NJR) REPORT ENCOMPASSES ALL 1,783 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY TWELVE (12) REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS II CR COCR FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE MBH. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE GENESIS II TOTAL KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF EIGHTY-EIGHT THOUSAND SEVEN HUNDRED THIRTY-SEVEN (88,737) KNEES UNDERWENT PRIMARY TKA IN WHICH A GENESIS II CR COCR FEMORAL COMPONENT WAS IMPLANTED IN UNITED KINGDOM BETWEEN (B)(6) 2003 AND (B)(6) 2026. THE CUMULATIVE REVISION RATES FOR GENESIS II CR COCR ARE NOT STATISTICALLY SIGNIFICANTLY DIFFERENT THAN THE CLASS AT 1-5 AND 20 YEARS OF FOLLOW-UP BASED ON OVERLAPPING CONFIDENCE INTERVALS. AT 10 AND 15 YEARS, THE REVISION RATE FOR GENESIS II CR COCR IS STATISTICALLY SIGNIFICANTLY LOWER THAN THE CLASS BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS. THE CUMULATIVE REVISION RATES WITH 95% CONFIDENCE INTERVALS OF THE CLASS WERE OBTAINED FROM THE 2025 NJR ANNUAL REPORT. THE FOLLOWING CUMULATIVE REVISION RATES WITH 95% CONFIDENCE INTERVALS ARE PRESENTED IN THIS REPORT: - AT 1ST POST-OPERATIVE YEAR: 0.40% (0.36%-0.45%) VS 0.39% (0.37%-0.40%) OF THE CLASS. - AT 3RD POST-OPERATIVE YEAR: 1.25% (1.17% - 1.33%) VS 1.26% (1.24%-1.29%) OF THE CLASS. - AT 5TH POST-OPERATIVE YEAR: 1.72% (1.63% -1.82%) VS 1.80% (1.77%-1.82%) OF THE CLASS. - AT 10TH POST-OPERATIVE YEAR: 2.50% (2.37%-2.64%) VS 2.69% (2.65%-2.73%) OF THE CLASS. - AT 15TH POST-OPERATIVE YEAR: 2.98% (2.80%-3.16%) VS 3.74% (3.68%-3.81%) OF THE CLASS. - AT 20TH POST-OPERATIVE YEAR: 3.97% (2.96%-5.31%) VS 5.28% (5.11%-5.46%) OF THE CLASS. BASED ON THESE STATISTICS, IT CAN BE CONCLUDED THAT THE GENESIS II CR COCR FEMORAL COMPONENT MEETS THE ANTICIPATED SURVIVORSHIP IN THE NJR. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

    Description of Event or Problem · 0

    BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN KNEE ARTHROPLASTY: 1. PRIMARY TKA PROCEDURES: - GENESIS II CR COCR FEMORAL COMPONENT: IMPLANTED IN EIGHTY-EIGHT THOUSAND SEVEN HUNDRED THIRTY-SEVEN (88,737) BETWEEN (B)(6) 2003 AND (B)(6) 2026. THIS TOTAL INCLUDES FEMORAL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JWH AND MBH. OF THE ONE THOUSAND SEVEN HUNDRED EIGHTY-THREE (1,783) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, TWELVE (12) REVISIONS WERE ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS II CR COCR FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE MBH. OF THESE, TWELVE (12) KNEES REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE (3) KNEES DUE TO INFECTION, TWO (2) KNEES DUE TO ASEPTIC LOOSENING OF THE FEMUR, TWO (2) KNEES DUE TO INSTABILITY, TWO (2) KNEES DUE TO OTHER REASONS, TWO (2) KNEES DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO UNEXPLAINED PAIN, AND ONE (1) KNEE DUE TO STIFFNESS, ONE (1) KNEE DUE TO ASEPTIC LOOSENING OF THE TIBIA, ONE (1) KNEE DUE TO TIBIAL LYSIS, AND ONE (1) KNEE DUE TO POLYETHYLENE COMPONENT WEAR. MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE REVISION CASE. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED BY THE NATIONAL JOINT REGISTRY (NJR) REPORT ENCOMPASSES ALL 1,783 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY TWELVE (12) REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS II CR COCR FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE MBH.

    Description of Event or Problem · 0

    Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2026-00318778-1-L1,10/2/2008,,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 4 LEFT,71422044,6CM08016A,71422044,,03596010496294,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Stiffness.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,59,Female,89,3/22/2007,,E1616,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L2,1/15/2009,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,07ct07803,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,64,Male,,8/23/2007,,E1906,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L3,1/21/2013,,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,6EM14486A,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other Inflammatory Arthropathy,44,Male,,9/7/2009,,E2127,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L4,5/2/2017,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,7GM06814A,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,53,Female,,9/21/2009,,E2330,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L5,4/25/2022,,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,6FM13985A,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Aseptic loosening Femur, Aseptic loosening Tibia, Wear of Polyethylene Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,61,Female,70,1/15/2010,4/25/2022,E161201,F1905,A0103;A040503,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L6,8/11/2015,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,7FM15628A,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Aseptic loosening Femur, Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,56,Female,,10/11/2010,,E161201;E2330,F1905,A0103;A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L7,9/15/2016,,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 6 RIGHT,71422032,12mm06737,71422032,,03596010496249,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other Inflammatory Arthropathy; Osteoarthritis,62,Male,,1/14/2014,,E2401,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L8,11/15/2016,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 4RT,71422028,13jm18793,71422028,,03596010496225,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,77,Female,,4/10/2014,,E2401,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L9,5/19/2016,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 7RT,71422034,13hm04176,71422034,,03596010496256,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,76,Male,,11/26/2014,,E1906,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L10,2/28/2017,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 5LT,71422046,14hm19811a,71422046,,03596010496300,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Instability.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,62,Female,,12/10/2015,,E1615,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L11,1/22/2025,,3/16/2026,GENESIS II TKA System,GENESIS II C/R HA POROUS FEMORAL SZ 6LT,71422048,15em16700,71422048,,03596010496317,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Lysis Tibia, Instability, Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,68,Female,,11/3/2016,1/22/2025,E1627;E1615;E2127,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2026-00318778-1-L12,4/11/2022,,3/16/2026,GENESIS II TKA System,GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 RIGHT,71422030,14jm16218a,71422030,,03596010496232,K030612,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eighty eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA between 11-Apr-2003 and 9-Jan-2026, using a GENESIS II CR CoCr Femoral Component. This total includes femoral components approved for use in the United States under FDA product codes JWH and MBH.;Of the one thousand seven hundred eighty?three (1,783) revision surgeries reported for these implants, twelve (12) revisions were associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Of these, twelve (12) knees required revision due to the following reasons: Three (3) knees due to infection, two (2) knees due to aseptic loosening of the femur, two (2) knees due to instability, two (2) knees due to other reasons, two (2) knees due to periprosthetic fracture, two (2) knees due to unexplained pain, and one (1) knee due to stiffness, one (1) knee due to aseptic loosening of the tibia, one (1) knee due to tibial lysis, and one (1) knee due to polyethylene component wear. Multiple reasons for revision may be listed for a single revision case. ;In consideration of the above, the analysis conducted by the National Joint Registry (NJR) report encompasses all 1,783 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only twelve (12) revisions associated with knees that had previously received a GENESIS II CR CoCr Femoral Component approved under FDA product code MBH.;Timeframe of Registry Data: Implantations conducted between 11-Apr-2003 and 9-Jan-2026 in United Kingdom.;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty?eight thousand seven hundred thirty-seven (88,737) knees underwent primary TKA in which a GENESIS II CR CoCr Femoral Component was implanted in United Kingdom between 11-Apr-2003 and 9-Jan-2026. ;The cumulative revision rates for GENESIS II CR CoCr are not statistically significantly different than the class at 1-5 and 20 years of follow-up based on overlapping confidence intervals. At 10 and 15 years, the revision rate for GENESIS II CR CoCr is statistically significantly lower than the class based on non-overlapping confidence intervals.;The cumulative revision rates with 95% confidence intervals of the class were obtained from the 2025 NJR Annual Report.;The following cumulative revision rates with 95% confidence intervals are presented in this report:;- At 1st post-operative year: 0.40% (0.36%-0.45%) vs 0.39% (0.37%-0.40%) of the class.;- At 3rd post-operative year: 1.25% (1.17% - 1.33%) vs 1.26% (1.24%-1.29%) of the class.;- At 5th post-operative year: 1.72% (1.63% -1.82%) vs 1.80% (1.77%-1.82%) of the class.;- At 10th post-operative year: 2.50% (2.37%-2.64%) vs 2.69% (2.65%-2.73%) of the class.;- At 15th post-operative year: 2.98% (2.80%-3.16%) vs 3.74% (3.68%-3.81%) of the class.;- At 20th post-operative year: 3.97% (2.96%-5.31%) vs 5.28% (5.11%-5.46%) of the class.;Based on these statistics, it can be concluded that the GENESIS II CR CoCr Femoral Component meets the anticipated survivorship in the NJR.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,78,Female,,5/4/2017,4/11/2022,E1906,F1905,A24,G07001,B20,C19,D12;D15,,0;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355704 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown