PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Report
- Report Number
- 1020279-2025-01692
- Event Type
- Injury
- Date Received
- October 15, 2025
- Report Date
- October 13, 2025
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- KRR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
REPORTING QUARTER: 3 (JULY 1 - SEPTEMBER 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT REPLACEMENT: A TOTAL OF FOUR HUNDRED AND FORTY-SEVEN (447) KNEES UNDERWENT PRIMARY PATELLOFEMORAL KNEE ARTHROPLASTY PROCEDURES BETWEEN (B)(6) 2013 AND (B)(6) 2024, USING A JOURNEY PATELLOFEMORAL JOINT REPLACEMENT. FROM THESE, SIXTY (60) 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 MALALIGNMENT, FOUR (4) KNEES DUE TO ASEPTIC LOOSENING, FIFTY (50) KNEES DUE TO OTHER- UNKNOWN REASONS. 2. REVISION TKA PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT REPLACEMENT: A TOTAL OF TWENTY-THREE (23) KNEES UNDERWENT REVISION PATELLOFEMORAL KNEE ARTHROPLASTY PROCEDURES BETWEEN (B)(6) 2014 AND (B)(6) 2023, USING A JOURNEY PATELLOFEMORAL JOINT REPLACEMENT. FROM THESE, SIX (6) KNEES WERE LATER RE-REVISED DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF 60 REVISIONS AND 6 RE-REVISIONS (66 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE EPRD FOR THE JOURNEY PATELLOFEMORAL JOINT REPLACEMENT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE JOURNEY PATELLOFEMORAL (PFJ) JOINT 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. MANUFACTURER¿S JOINT REGISTRY REPORT FOR THE JOURNEY PATELLOFEMORAL JOINT (PFJ) REPLACEMENT PROVIDED DATA USAGE IN PRIMARY AND REVISION TKA. DURING PRIMARY PROCEDURES, THE CUMULATIVE REVISION RATES FOR THE JOURNEY PFJ KNEE SYSTEM WERE IN LINE WITH THE CLASS DEVICE AT 8 YEARS OF FOLLOW UP, WHEN CONSIDERING THE CONFIDENCE INTERVALS. DURING REVISION PROCEDURES, THE CUMULATIVE RE-REVISION RATES FOR THE JOURNEY PFJ KNEE SYSTEM WERE IN LINE WITH THE CLASS DEVICE AT 6 YEARS OF FOLLOW UP, WHEN CONSIDERING THE CONFIDENCE INTERVALS. DUE TO A LOW NUMBER OF IMPLANTATIONS AT RISK, THE CONFIDENCE INTERVALS ASSOCIATED WITH THE CUMULATIVE RE-REVISION RATES OF JOURNEY PFJ IMPLANTATIONS ARE WIDE. THE REASONS FOR REVISION AND RE-REVISION FOR THE JOURNEY PFJ KNEE SYSTEM WERE IN LINE WITH THE RESPECTIVE CLASS DEVICE. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.
Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00287415-1-L1,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later re-revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these, six (6) knees were later re-revised due to other- unknown reasons. ;;Timeframe of Registry data: Implantations conducted between 01-Oct-2014 and 31-Aug-2023 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 twenty-three (23) procedures with Journey PFJ were performed in Germany between 01-Oct-2014 and 31-Aug-2023. The cumulative re-revision rates for the JOURNEY PFJ Knee System were in line with the class device across 6 years of follow up, when considering the confidence intervals. Due to a low number of implantations at risk (23 implantations with Journey PFJ) vs the class (48,344 implantations), the confidence intervals associated with the cumulative re-revision rates of JOURNEY PFJ implantations are wide. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year: 9.3% (0.0%¿20.8%) vs 5.6% (5.4%¿5.9%) of the class.;¿ At 2nd postoperative year: 28.7% (6.3%¿45.8%) vs 9.9% (9.6%¿10.1%) of the class.;¿ At 3rd postoperative year: 28.7% (6.3%¿45.8%) vs 12.4% (12.0%¿12.7%) of the class.;¿ At 4th postoperative year: 28.7% (6.3%¿45.8%) vs 14.3% (13.9%¿14.6%) of the class.;¿ At 5th postoperative year: 28.7% (6.3%¿45.8%) vs 15.6% (15.2%¿16.0%) of the class.;¿ At 6th postoperative year: 28.7% (6.3%¿45.8%) vs 16.8% (16.4%¿17.3%) 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-2025-00287415-1-L2,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later re-revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these, six (6) knees were later re-revised due to other- unknown reasons. ;;Timeframe of Registry data: Implantations conducted between 01-Oct-2014 and 31-Aug-2023 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 twenty-three (23) procedures with Journey PFJ were performed in Germany between 01-Oct-2014 and 31-Aug-2023. The cumulative re-revision rates for the JOURNEY PFJ Knee System were in line with the class device across 6 years of follow up, when considering the confidence intervals. Due to a low number of implantations at risk (23 implantations with Journey PFJ) vs the class (48,344 implantations), the confidence intervals associated with the cumulative re-revision rates of JOURNEY PFJ implantations are wide. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year: 9.3% (0.0%¿20.8%) vs 5.6% (5.4%¿5.9%) of the class.;¿ At 2nd postoperative year: 28.7% (6.3%¿45.8%) vs 9.9% (9.6%¿10.1%) of the class.;¿ At 3rd postoperative year: 28.7% (6.3%¿45.8%) vs 12.4% (12.0%¿12.7%) of the class.;¿ At 4th postoperative year: 28.7% (6.3%¿45.8%) vs 14.3% (13.9%¿14.6%) of the class.;¿ At 5th postoperative year: 28.7% (6.3%¿45.8%) vs 15.6% (15.2%¿16.0%) of the class.;¿ At 6th postoperative year: 28.7% (6.3%¿45.8%) vs 16.8% (16.4%¿17.3%) 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-2025-00287415-1-L3,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later re-revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these, six (6) knees were later re-revised due to other- unknown reasons. ;;Timeframe of Registry data: Implantations conducted between 01-Oct-2014 and 31-Aug-2023 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 twenty-three (23) procedures with Journey PFJ were performed in Germany between 01-Oct-2014 and 31-Aug-2023. The cumulative re-revision rates for the JOURNEY PFJ Knee System were in line with the class device across 6 years of follow up, when considering the confidence intervals. Due to a low number of implantations at risk (23 implantations with Journey PFJ) vs the class (48,344 implantations), the confidence intervals associated with the cumulative re-revision rates of JOURNEY PFJ implantations are wide. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year: 9.3% (0.0%¿20.8%) vs 5.6% (5.4%¿5.9%) of the class.;¿ At 2nd postoperative year: 28.7% (6.3%¿45.8%) vs 9.9% (9.6%¿10.1%) of the class.;¿ At 3rd postoperative year: 28.7% (6.3%¿45.8%) vs 12.4% (12.0%¿12.7%) of the class.;¿ At 4th postoperative year: 28.7% (6.3%¿45.8%) vs 14.3% (13.9%¿14.6%) of the class.;¿ At 5th postoperative year: 28.7% (6.3%¿45.8%) vs 15.6% (15.2%¿16.0%) of the class.;¿ At 6th postoperative year: 28.7% (6.3%¿45.8%) vs 16.8% (16.4%¿17.3%) 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-2025-00287415-1-L4,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later re-revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these, six (6) knees were later re-revised due to other- unknown reasons. ;;Timeframe of Registry data: Implantations conducted between 01-Oct-2014 and 31-Aug-2023 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 twenty-three (23) procedures with Journey PFJ were performed in Germany between 01-Oct-2014 and 31-Aug-2023. The cumulative re-revision rates for the JOURNEY PFJ Knee System were in line with the class device across 6 years of follow up, when considering the confidence intervals. Due to a low number of implantations at risk (23 implantations with Journey PFJ) vs the class (48,344 implantations), the confidence intervals associated with the cumulative re-revision rates of JOURNEY PFJ implantations are wide. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year: 9.3% (0.0%¿20.8%) vs 5.6% (5.4%¿5.9%) of the class.;¿ At 2nd postoperative year: 28.7% (6.3%¿45.8%) vs 9.9% (9.6%¿10.1%) of the class.;¿ At 3rd postoperative year: 28.7% (6.3%¿45.8%) vs 12.4% (12.0%¿12.7%) of the class.;¿ At 4th postoperative year: 28.7% (6.3%¿45.8%) vs 14.3% (13.9%¿14.6%) of the class.;¿ At 5th postoperative year: 28.7% (6.3%¿45.8%) vs 15.6% (15.2%¿16.0%) of the class.;¿ At 6th postoperative year: 28.7% (6.3%¿45.8%) vs 16.8% (16.4%¿17.3%) 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-2025-00287415-1-L5,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later re-revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these, six (6) knees were later re-revised due to other- unknown reasons. ;;Timeframe of Registry data: Implantations conducted between 01-Oct-2014 and 31-Aug-2023 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 twenty-three (23) procedures with Journey PFJ were performed in Germany between 01-Oct-2014 and 31-Aug-2023. The cumulative re-revision rates for the JOURNEY PFJ Knee System were in line with the class device across 6 years of follow up, when considering the confidence intervals. Due to a low number of implantations at risk (23 implantations with Journey PFJ) vs the class (48,344 implantations), the confidence intervals associated with the cumulative re-revision rates of JOURNEY PFJ implantations are wide. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year: 9.3% (0.0%¿20.8%) vs 5.6% (5.4%¿5.9%) of the class.;¿ At 2nd postoperative year: 28.7% (6.3%¿45.8%) vs 9.9% (9.6%¿10.1%) of the class.;¿ At 3rd postoperative year: 28.7% (6.3%¿45.8%) vs 12.4% (12.0%¿12.7%) of the class.;¿ At 4th postoperative year: 28.7% (6.3%¿45.8%) vs 14.3% (13.9%¿14.6%) of the class.;¿ At 5th postoperative year: 28.7% (6.3%¿45.8%) vs 15.6% (15.2%¿16.0%) of the class.;¿ At 6th postoperative year: 28.7% (6.3%¿45.8%) vs 16.8% (16.4%¿17.3%) 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-2025-00287415-1-L6,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later re-revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of twenty-three (23) knees underwent revision patellofemoral knee arthroplasty procedures between 01-Oct-2014 and 31-Aug-2023, using a Journey Patellofemoral Joint Component. From these, six (6) knees were later re-revised due to other- unknown reasons. ;;Timeframe of Registry data: Implantations conducted between 01-Oct-2014 and 31-Aug-2023 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 twenty-three (23) procedures with Journey PFJ were performed in Germany between 01-Oct-2014 and 31-Aug-2023. The cumulative re-revision rates for the JOURNEY PFJ Knee System were in line with the class device across 6 years of follow up, when considering the confidence intervals. Due to a low number of implantations at risk (23 implantations with Journey PFJ) vs the class (48,344 implantations), the confidence intervals associated with the cumulative re-revision rates of JOURNEY PFJ implantations are wide. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year: 9.3% (0.0%¿20.8%) vs 5.6% (5.4%¿5.9%) of the class.;¿ At 2nd postoperative year: 28.7% (6.3%¿45.8%) vs 9.9% (9.6%¿10.1%) of the class.;¿ At 3rd postoperative year: 28.7% (6.3%¿45.8%) vs 12.4% (12.0%¿12.7%) of the class.;¿ At 4th postoperative year: 28.7% (6.3%¿45.8%) vs 14.3% (13.9%¿14.6%) of the class.;¿ At 5th postoperative year: 28.7% (6.3%¿45.8%) vs 15.6% (15.2%¿16.0%) of the class.;¿ At 6th postoperative year: 28.7% (6.3%¿45.8%) vs 16.8% (16.4%¿17.3%) 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-L1,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to infection. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L2,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to infection. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L3,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to infection. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L4,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to infection. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L5,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to dislocation or instability. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L6,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to malalignment. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287411-1-L7,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to aseptic loosening. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L8,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to aseptic loosening. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L9,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to aseptic loosening. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L10,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to aseptic loosening. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L11,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L12,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L13,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L14,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L15,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L16,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L17,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L18,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L19,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L20,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L21,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L22,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L23,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L24,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L25,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L26,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L27,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L28,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L29,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L30,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L31,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L32,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L33,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L34,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L35,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L36,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L37,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L38,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L39,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L40,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L41,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L42,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L43,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L44,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L45,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L46,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L47,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L48,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L49,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L50,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L51,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L52,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L53,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L54,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L55,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L56,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L57,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L58,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L59,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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-L60,,10/13/2025,7/1/2025,JOURNEY PFJ,JOURNEY PFJ,,,,,,K051086,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these,one (1) knee was later revised due to other-unknown reasons. ","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred and forty-seven (447) knees underwent primary patellofemoral knee arthroplasty procedures between 01-Sep-2013 and 31-Mar-2024, using a Journey Patellofemoral Joint Component. From these, sixty (60) 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 malalignment, four (4) knees due to aseptic loosening, fifty (50) knees due to other- unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Sep-2013 and 31-Mar-2024 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 four hundred and forty-seven (447) procedures with Journey PFJ were performed in Germany between 01-Sep-2013 and 31-Mar-2024. The cumulative revision rates for the JOURNEY PFJ Knee System were in line with the class device between 2 to 8 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: 6.8% (4.3%¿9.2%) vs 2.9% (1.5%¿4.2%) of the class.;¿ At 2nd postoperative year: 10.1% (7.1%¿13.0%) vs 7.1% (4.9%¿9.3%) of the class.;¿ At 3rd postoperative year: 12.8% (9.3%¿16.1%) vs 9.3% (6.7%¿11.8%) of the class.;¿ At 4th postoperative year: 15.5% (11.5%¿19.4%) vs 12.2% (9.1%¿15.2%) of the class.;¿ At 5th postoperative year: 16.6% (12.3%¿20.7%) vs 14.6% (11.0%¿18.1%) of the class.;¿ At 6th postoperative year: 18.4% (13.5%¿23.0%) vs 16.2% (12.2%¿19.9%) of the class.;¿ At 7th postoperative year: 20.0% (14.2%¿25.4%) vs 17.0% (12.7%¿21.1%) of the class.;¿ At 8th postoperative year: 22.1% (15.0%¿28.6%) vs 21.2% (14.8%¿27.1%) 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;
BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT REPLACEMENT: A TOTAL OF FOUR HUNDRED AND FORTY-SEVEN (447) KNEES UNDERWENT PRIMARY PATELLOFEMORAL KNEE ARTHROPLASTY PROCEDURES BETWEEN (B)(6) 2013 AND (B)(6) 2024, USING A JOURNEY PATELLOFEMORAL JOINT REPLACEMENT. FROM THESE, SIXTY (60) 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 MALALIGNMENT, FOUR (4) KNEES DUE TO ASEPTIC LOOSENING, FIFTY (50) KNEES DUE TO OTHER- UNKNOWN REASONS. 2. REVISION TKA PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT REPLACEMENT: A TOTAL OF TWENTY-THREE (23) KNEES UNDERWENT REVISION PATELLOFEMORAL KNEE ARTHROPLASTY PROCEDURES BETWEEN (B)(6) 2014 AND (B)(6) 2023, USING A JOURNEY PATELLOFEMORAL JOINT REPLACEMENT. FROM THESE, SIX (6) KNEES WERE LATER RE-REVISED DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF 60 REVISIONS AND 6 RE-REVISIONS (66 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE EPRD FOR THE JOURNEY PATELLOFEMORAL JOINT REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180482 | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | KRR | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Unknown | Required Intervention |