Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Description of Event or Problem

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-2025-00287411-1-L61,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to aseptic loosening. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L62,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to wear. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L63,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L64,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L65,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L66,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L67,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L68,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L69,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L70,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L71,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L72,,,6/3/2026,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of five hundred fifty-eight (558) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2025, using a Journey Patellofemoral Joint Component. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons.;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2025 in Germany. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 1st postoperative year: 6.2% (4.1%¿8.3%) vs 3.1% (1.8%¿4.3%) of the class.;-At 2nd postoperative year: 9.0% (6.4%¿11.5%) vs 6.9% (4.9%¿8.8%) of the class.;-At 3rd postoperative year: 12.4% (9.2%¿15.4%) vs 9.4% (7.0%¿11.7%) of the class.;-At 4th postoperative year: 15.3% (11.6%¿18.8%) vs 12.0% (9.2%¿14.7%) of the class.;-At 5th postoperative year: 16.1% (12.3%¿19.8%) vs 14.2% (11.0%¿17.2%) of the class.;-At 7th postoperative year: 19.0% (14.2%¿23.4%) vs 15.9% (12.3%¿19.3%) of the class.;-At 9th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;-At 10th postoperative year: 22.7% (15.5%¿29.3%) vs 19.1% (14.4%¿23.5%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem

Based on real world data from the Endoprothesenregister Deutschland (EPRD), several revision surgeries have been reported in the Germany following the use of Smith+Nephew prostheses in knee procedures: 1. Primary Knee Procedures: Journey Patellofemoral Joint Component: Implanted in a total of five hundred fifty-eight (558) knees between 01-Sep-2013 and 31-Mar-2025. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons. Of the 72 total revision surgeries, 60 were previously submitted to FDA and 12 new revisions were identified during this reporting quarter.

Additional Manufacturer Narrative

Reporting Quarter: 2 (April 1 - June 30, 2026). Summary of adverse events: Based on real world data from the Endoprothesenregister Deutschland (EPRD), several revision surgeries have been reported in the Germany following the use of Smith+Nephew prostheses in knee procedures:1. Primary Knee Procedures: Journey Patellofemoral Joint Component: Implanted in a total of five hundred fifty-eight (558) knees between 01-Sep-2013 and 31-Mar-2025. From these, seventy-two (72) knees were later revised due to the following reasons: four (4) knees due to infection, one (1) knee due to dislocation or instability, one (1) knee due to malposition/malalignment, five (5) knees due to aseptic loosening, one (1) knee due to wear, and sixty (60) knees due to other- unknown reasons. Of the 72 total revision surgeries, 60 were previously submitted to FDA and 12 new revisions were identified during this reporting quarter. Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ 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 five hundred fifty-eight (558) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2025. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 1 to 10 years of follow up, based on overlapping confidence intervals. Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.