FDA Adverse Event Injury Summary report: Y

PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

MDR report key: 23295098 · Received October 15, 2025

Report

Report Number: 1020279-2025-01702
Event Type: Injury
Date Received: October 15, 2025
Report Date: October 28, 2025
Manufacturer: SMITH & NEPHEW, INC.
Product Code: KRR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01702, PREVIOUSLY SUBMITTED ON 14-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN THE ATTACHED .CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: (B)(4) (L1-L106, L108-L112, L114-L359, L361-L514). (B)(4) (L1-L11). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE .CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01702.

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 3 (JULY 1 - SEPTEMBER 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY PATELLOFEMORAL JOINT (PFJ) REPLACEMENT PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT (PFJ) OXINIUM COMPONENTS: IMPLANTED IN A TOTAL OF TWO THOUSAND EIGHT HUNDRED AND NINETY-FOUR (2,894) KNEES BETWEEN 13-OCT-2005 AND 20-MAY-2025. FROM THESE, FIVE HUNDRED FOURTEEN (514) KNEES WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO HUNDRED AND EIGHTY-FOUR (284) KNEES DUE TO PROGRESSIVE ARTHRITIS REMAINING, ONE HUNDRED (100) KNEES DUE TO PAIN, SIXTY-EIGHT (68) KNEES DUE TO WEAR OF THE POLYETHYLENE COMPONENT, THIRTY (30) KNEES DUE TO MALALIGNMENT, TWENTY-EIGHT (28) KNEES DUE TO ASEPTIC LOOSENING OF THE PATELLA, TWENTY-ONE (21) KNEES DUE TO INSTABILITY, EIGHTEEN (18) KNEES DUE TO DISLOCATION OR SUBLUXATION, THIRTEEN (13) KNEES DUE TO ASEPTIC LOOSENING OF THE FEMUR, THIRTEEN (13) KNEES DUE TO INFECTION, TEN (10) KNEES DUE TO STIFFNESS, EIGHT (8) KNEES DUE TO COMPONENT DISSOCIATION, EIGHT (8) KNEES DUE TO PERIPROSTHETIC FRACTURE, FIVE (5) KNEES DUE TO ASEPTIC LOOSENING OF THE TIBIA, FOUR (4) KNEES DUE TO IMPLANT FRACTURE, THREE (3) KNEES DUE TO LYSIS OF THE TIBIA, ONE (1) KNEE DUE TO LYSIS OF THE FEMUR, AND FORTY-NINE (49) KNEES DUE TO OTHER-UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. 2. REVISION PATELLOFEMORAL JOINT (PFJ) REPLACEMENT PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT (PFJ) OXINIUM COMPONENTS: IMPLANTED IN A TOTAL OF FORTY-FOUR (44) KNEES BETWEEN 3-NOV-2007 AND 24-MAR-2025. FROM THESE, ELEVEN (11) KNEES WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: FIVE (5) KNEES DUE TO PROGRESSIVE ARTHRITIS REMAINING, THREE (3) KNEES DUE TO WEAR OF THE POLYETHYLENE COMPONENT, TWO (2) KNEES DUE TO DISLOCATION OR SUBLUXATION, TWO (2) KNEES DUE TO PAIN, ONE (1) KNEE DUE TO INFECTION, ONE (1) KNEE DUE TO INSTABILITY, AND ONE (1) KNEE DUE TO LYSIS OF THE FEMUR. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF FIVE HUNDRED AND FOURTEEN (514) REVISIONS AND ELEVEN (11) RE-REVISIONS HAVE BEEN REPORTED IN THE NJR FOR THE JOURNEY PATELLOFEMORAL JOINT (PFJ) OXINIUM COMPONENT, RESULTING IN A TOTAL OF 525 EVENTS SUMMARIZED THROUGH THIS 3500A FORM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE JOURNEY PATELLOFEMORAL JOINT (PFJ) 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. NJR REPORTS FOR THE JOURNEY PATELLOFEMORAL JOINT (PFJ) KNEE SYSTEM DURING PRIMARY AND REVISION PROCEDURES WERE REVIEWED. FOR PRIMARY PROCEDURES, THE CUMULATIVE REVISION RATES OF JOURNEY PFJ IMPLANTS (19.64%) WAS SIGNIFICANTLY HIGHER THAN THE CLASS DEVICE (16.90%) AT 10 YEARS OF FOLLOW-UP BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. THE MOST COMMON REASON FOR REVISION IS PROGRESSIVE OA (9.8%), WHICH IS A COMMON REASON FOR REVISION AFTER PATELLOFEMORAL IMPLANTATIONS AND MAY BE RELATED TO A NUMBER OF FACTORS BEYOND THE PERFORMANCE OF THE DEVICE. ADDITIONALLY, THE MEAN AGE OF IMPLANTATION WITH JOURNEY PFJ IMPLANTS WAS 58.5 YEARS. A LOWER IMPLANTATION AGE, AS SEEN WITH SIMILAR OXINIUM IMPLANTS, AFFORDS MORE PATIENT LIFESPAN AFTER IMPLANTATION AND SUBSEQUENTLY GREATER RISK FOR PATIENT-RELATED REASONS FOR REVISION RESULTING ACTIVITIES OF DAILY LIVING. DURING REVISION PROCEDURES, THE CUMULATIVE RE-REVISION RATES FOR THE JOURNEY PFJ SYSTEM WERE SIGNIFICANTLY HIGHER THAN THE CLASS DEVICE, BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. HOWEVER, THE CUMULATIVE RE-REVISION RATES FOR THE SUBJECT DEVICE MAY HAVE A LOW STATISTICAL RELIABILITY DUE TO THE LOW NUMBER OF IMPLANTATIONS FOR THE SUBJECT DEVICE. SIMILAR TO PRIMARY IMPLANTATIONS WITH JOURNEY PFJ IMPLANTS, THE MEAN AGE OF IMPLANTATION DURING REVISION PROCEDURES WEAS 61.2 YEARS WHICH ALLOWS FOR PATIENT-RELATED FACTORS SUCH AS AN ACTIVE LIFESTYLE TO CONTRIBUTE TO REASONS FOR REVISION SUCH AS IMPLANT WEARING. SPECIFIC ANALYSIS FOR EACH COMBINATION 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.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00287076-1-L1,4/11/2007,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06em06657,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Male,,10/13/2006,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L2,4/11/2007,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06cm15379,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Male,,10/13/2006,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L3,11/3/2007,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,06JM07238,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,9/8/2007,11/3/2007,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L4,2/7/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,6GM09555,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,6/1/2007,,E2330;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L5,4/24/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,05km02540,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Male,,3/9/2006,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L6,8/5/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,7DM04413,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,,8/14/2007,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L7,9/17/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,7EM22038,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,10/23/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L8,11/12/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM13622,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Female,,9/12/2007,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L9,11/20/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06AM13530,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,83,Female,,3/10/2006,,E1615;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L10,12/3/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06EM14154,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Male,,11/1/2006,12/3/2008,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L11,12/15/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,06GM07921,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Male,,4/18/2007,12/15/2008,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L12,2/23/2009,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,7EM07699,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,1/18/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L13,9/10/2009,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,06cm03906,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,6/1/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L14,9/15/2009,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,07GM11819,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Male,,10/23/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L15,11/4/2009,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06DM04808,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Female,,2/13/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L16,11/17/2009,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08EM22371,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,12/19/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L17,1/21/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,08jm11446,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,91,9/10/2009,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L18,1/29/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08KM00451,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Stiffness.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,1/27/2009,,E2330;E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L19,2/17/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08EM22371,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: Osteoarthritis, other-unspecified reasons.",48,Female,122,7/7/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L20,2/22/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08CM08422,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,,7/2/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L21,2/27/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,06fm18579,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,12/15/2006,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L22,3/2/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08AM07446,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Component Dissociation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,45,Male,96,5/5/2009,,E1615,F1905,A24;A051201,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L23,3/24/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,08LM04459,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Male,,2/11/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L24,4/27/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08CM18260,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,68,7/4/2008,,E161201;E2401,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L25,5/20/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08CM04951,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,7/24/2008,,E1614;E1602,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L26,6/3/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08MM01447,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Male,,6/19/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L27,6/30/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06FM19943,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Female,58,7/5/2007,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L28,7/14/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,06EM00801,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,44,Male,92,6/4/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L29,9/22/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,7FM13143,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,48,Male,67,1/21/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L30,9/27/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08HM18322,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,,7/20/2010,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L31,10/11/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,7LM14721,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,8/2/2008,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L32,11/5/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09em06027,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,85,Male,,11/29/2009,11/5/2010,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L33,11/17/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,08jm13499,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,37,Female,,9/2/2009,11/17/2010,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L34,11/30/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08cm09792,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,,11/20/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L35,12/2/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08fm06643,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Male,79,1/29/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L36,12/8/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,06JM05477,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,79,8/13/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L37,12/9/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,09AM15964A,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,,5/8/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L38,12/17/2010,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,05lm03416,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Implant fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Male,,7/20/2006,,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L39,2/4/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,07JM15701,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Male,133,10/1/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L40,2/14/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07EM09692,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,7/12/2008,,E2401;E2308,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L41,2/15/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07hm20574r,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Male,,5/21/2009,,E161201;E2330,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L42,2/21/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,07DM09261,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Male,,2/19/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L43,4/4/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07FM06130,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Male,,4/14/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L44,4/19/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07CM21396,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: Osteoarthritis, other-unspecified reasons.",51,Female,67,1/27/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L45,5/20/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06GM10578,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,48,Female,,2/16/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L46,5/23/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,7DM18206,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Male,,7/9/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L47,6/16/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09FM21696,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,2/19/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L48,6/21/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07HM20574R,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,39,Male,,12/4/2007,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L49,6/30/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07em11920a,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Female,81,10/17/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L50,7/8/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06gm09554,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,10/19/2007,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L51,7/11/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06gm11350,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,42,Female,,2/28/2011,,E1615;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L52,7/14/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08FM14099A,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,84,3/9/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L53,7/29/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10dm00253,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,7/15/2010,,E1615;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L54,8/9/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09CM16387,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Female,,1/6/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L55,8/17/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11bm16637,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,5/20/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L56,8/25/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,9BM03223,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Male,143,1/28/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L57,9/15/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,10CM05603,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Male,105,4/21/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L58,11/1/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09GM07787,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,10/19/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L59,11/7/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09EM06027,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,42,Female,64,2/5/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L60,11/29/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,8DM08723,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Male,,10/1/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L61,12/1/2011,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08jm17331,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,104,4/2/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L62,1/5/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,06HM13786,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: Osteoarthritis, other-unspecified reasons.",52,Female,83,1/27/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L63,2/6/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10em10768,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,7/18/2011,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L64,2/22/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,8MM14495,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,,10/17/2009,,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L65,3/3/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07DM03942,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,,2/19/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L66,3/5/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06bm17047,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Instability, Malalignment, Aseptic loosening Patella, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,82,Female,,4/27/2006,,E1614;E1615;E2308;E161201;E1602,F1905,A24;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L67,3/20/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07dm09263,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,93,6/1/2007,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L68,3/21/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,09AM21853A,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,84,10/20/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L69,3/22/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06hm06052,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,80,Female,,6/1/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L70,3/22/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10BM06841,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,102,7/21/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L71,3/26/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,7HM10773,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,80,Female,,2/8/2008,,E1614;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L72,3/28/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07DM18206,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,10/1/2007,,E2330,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L73,5/14/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,7CM15808,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Male,,1/17/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L74,5/17/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,07fm5246,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,69,9/4/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L75,5/22/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09EM15445,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Male,,8/23/2011,,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L76,5/23/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,9BM19543,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,8/17/2010,,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L77,6/7/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07dm20583,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,5/22/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L78,6/11/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,8KM01452,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Stiffness, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,,1/29/2010,,E2330;E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L79,6/11/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08lm16295,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,69,4/29/2010,,E1906;E161201,F1905,A24;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L80,6/12/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06GM11350,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,3/19/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L81,6/14/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08GM19390,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,2/21/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L82,7/10/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08JM17331,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Female,83,2/4/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L83,7/16/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08KM17133,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,93,6/8/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L84,7/16/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07am09279,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,8/12/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L85,7/18/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09CM05014,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,12/17/2010,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L86,7/25/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10km04262,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Periprosthetic Fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,11/30/2011,,E2127,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L87,8/2/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07FM11583,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,102,7/8/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L88,8/4/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,06jm07511,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,65,11/18/2009,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L89,8/10/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09bm19542,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Male,,4/26/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L90,8/10/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,10hm02545,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Male,,1/31/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L91,8/13/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10bm15601,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,6/17/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L92,9/4/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,9BM04565,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,79,8/17/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L93,9/17/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,6HM06619,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,1/28/2007,,E2330,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L94,9/21/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07FM17737,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,94,8/27/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L95,9/24/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07HM02229,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,5/20/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L96,9/27/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10GM02010,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,83,Male,,10/14/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L97,9/28/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,08MM08314,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,11/18/2009,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L98,10/3/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08fm02090,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,44,Female,,5/11/2009,,E2330,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L99,10/11/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08AM24536,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,57,6/17/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L100,10/12/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM19467,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Male,,5/24/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L101,10/16/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07gm01004,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Malalignment, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,,10/14/2010,,E2330;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L102,10/30/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,08DM20242,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,6/6/2008,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L103,11/19/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM19467,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,43,Female,76,4/11/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L104,11/28/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06FM19455,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,32,Female,,6/20/2007,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L105,12/11/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,09bm18439,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Male,127,5/25/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L106,1/4/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11cm05210b,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,109,1/27/2012,,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L107,1/11/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),MEDIUM PATELLA FEM IMPLANT RT,71932207,05jm07268,71932207,,,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,3/17/2006,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L108,1/21/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,6FM06576,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Male,,10/23/2007,,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L109,2/9/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,06DM12451,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Stiffness, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,5/21/2007,,E1614;E1616;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L110,2/27/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,06CM08094,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Stiffness.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,32,Female,,11/26/2007,,E2330;E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L111,3/6/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,6JM09443,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Male,,9/16/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L112,3/8/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07JM01419,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,41,Female,,3/27/2012,,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L113,3/14/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),MEDIUM PATELLA FEM IMPLANT RT,71932207,05jm07268,71932207,,,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,10/31/2005,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L114,3/16/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06HM08689,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Implant fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,90,Female,71,4/14/2007,,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L115,4/24/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,06CM01739,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,85,5/23/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L116,5/3/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09EM06027,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,6/10/2011,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L117,5/11/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,05KM02540,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Male,,1/21/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L118,6/12/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07EM08654,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,11/21/2007,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L119,6/17/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,08GM12839,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,6/8/2012,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L120,6/29/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07cm14196,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,58,Female,93,12/4/2007,,E1614;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L121,7/1/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,09cm00422a,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,45,Female,,6/16/2010,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L122,7/11/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08HM12916,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,6/25/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L123,7/29/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09MM05509,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Male,100,9/19/2011,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L124,8/1/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07jm09809a,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,,4/3/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L125,8/19/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08km00451,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,2/13/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L126,10/7/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07em10937a,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,57,10/13/2008,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L127,10/23/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,08EM21217,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Lysis Tibia, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,76,12/19/2012,,E1627;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L128,10/24/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,9AM17644,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,81,10/15/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L129,11/26/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07DM14925,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,101,7/8/2008,,E2330;E161201,F1905,A24;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L130,11/29/2013,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06am16920,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,6/8/2006,,E1615;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L131,2/10/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,12EM15634,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Component Dissociation, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,10/9/2012,,E2330,F1905,A051201;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L132,2/19/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,8DM11833,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,10/30/2008,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L133,2/28/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,8DM05474,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,41,Female,,12/29/2009,,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L134,3/3/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,07dm08466,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,8/23/2010,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L135,3/4/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,06gmo4332,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,52,Female,67,12/18/2008,,E1615;E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L136,3/14/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,10mm06331,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,1/27/2012,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L137,3/27/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11lm11947,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Stiffness.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,43,Male,,2/23/2013,,E2330;E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L138,4/30/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11cm05211,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,11/22/2012,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L139,5/7/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,7KM14073,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Malalignment, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,3/19/2008,,E2308;E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L140,6/13/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10FM,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,8/24/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L141,6/20/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06DM09706,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,6/1/2006,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L142,7/10/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,10EM14908,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,2/10/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L143,7/21/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,11CM20340,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Female,,9/23/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L144,7/24/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,13EM13612,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,75,9/27/2013,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L145,7/29/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09AM05830,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,71,Male,70,8/18/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L146,8/4/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06gm09555,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,8/10/2007,,E2401;E2308,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L147,8/4/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07HM14458R,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,44,Female,,6/28/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L148,9/9/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,1245,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,,9/5/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L149,9/16/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,08fm18778,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,4/2/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L150,9/23/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,11BM10183,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Male,,12/22/2011,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L151,10/13/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,O7HMO9794,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,3/4/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L152,10/20/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09mm08423,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,118,8/13/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L153,11/6/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,07JM01025R,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Female,,12/1/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L154,11/21/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,9BM14266,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,,12/6/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L155,11/27/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,12jm04254,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Male,,1/20/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L156,12/1/2014,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,2MM12846,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Unexplained Pain, Stiffness, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Male,,12/11/2013,,E161201;E2330;E1616,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L157,1/12/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06FM17673,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,2/28/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L158,1/20/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09CM05015,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,73,3/17/2010,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L159,1/21/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,10FM16268,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,3/14/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L160,1/23/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,4AM11624,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,90,7/26/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L161,2/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,10EM08153,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,,4/2/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L162,2/5/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10FM08916,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,1/27/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L163,2/9/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09AM17644,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,84,11/9/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L164,2/9/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,2LM09100,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,45,Female,,8/23/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L165,2/24/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08AM21846,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,111,1/9/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L166,3/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08CM15344,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,3/30/2009,,E1614;E2308,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L167,3/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,2FM15473,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Male,,12/12/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L168,3/25/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08CM21928,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,77,Male,,9/26/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L169,4/2/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13GM16094,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,8/7/2014,,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L170,4/28/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM17671,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,87,Female,69,11/7/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L171,4/29/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,7DM07022,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,10/2/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L172,5/5/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,09EM11193,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Male,79,9/30/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L173,5/11/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,06EM07710,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Female,,2/5/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L174,5/15/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11CM06238,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,80,Male,,6/28/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L175,6/11/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09CM07283,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,5/5/2010,,E2330,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L176,7/16/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07FM13143,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,,10/12/2009,,E161201;E2401,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L177,7/17/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,8BM16256A,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,2/24/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L178,7/27/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,13LM04424,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,8/8/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L179,8/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,11CM17723,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection, Component Dissociation, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,45,Female,,7/31/2012,,E1906;E161201,F1905,A24;A051201;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L180,8/10/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13CM14214,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,1/19/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L181,8/17/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07LM11542,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,130,3/26/2009,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L182,8/17/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,11CM20342,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,,2/20/2012,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L183,9/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,11km13809a,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,7/24/2012,,E2330;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L184,9/5/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10bm09022,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Lysis Tibia.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,1/12/2011,,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L185,9/10/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,8HM09491,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,4/27/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L186,9/14/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12CM01642,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,11/5/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L187,9/23/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08DM01671,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,11/7/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L188,9/23/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,08em15894b,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,4/24/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L189,9/29/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13dm08514,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,12/31/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L190,10/6/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,13dm17489,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,85,Female,70,8/20/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L191,10/13/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,0,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,12/5/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L192,11/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11BM06210,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,10/2/2012,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L193,11/13/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13GM06864,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,,5/16/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L194,11/19/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,14cm17773,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,46,Female,76,2/5/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L195,12/1/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12FM13440,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,79,Male,93,3/21/2013,,E1615;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L196,12/4/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,1212121,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Male,,11/30/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L197,12/11/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06HM06619,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,87,Female,,3/17/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L198,12/14/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,8BM07811,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,5/24/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L199,12/14/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,9BM18439,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,11/9/2009,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L200,12/23/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11EM12528,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Male,,1/20/2012,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L201,12/30/2015,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,13lm16005,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,43,Female,,11/26/2014,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L202,2/4/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12b17323,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,88,Male,,5/21/2012,,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L203,2/9/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09bm16631,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,79,Female,,11/26/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L204,2/10/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10HM11941,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,79,Female,,6/20/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L205,3/9/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,07fm05246,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,4/30/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L206,3/9/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,13CM16928,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,86,2/3/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L207,3/22/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,13mm04272,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,,8/25/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L208,4/4/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11hm16049,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,108,1/20/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L209,4/4/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15em18606,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Male,,11/30/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L210,4/5/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11JM08623,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,73,8/2/2012,,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L211,4/7/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11HM17115,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,82,7/5/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L212,4/11/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,7EM03749,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Component Dissociation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,89,Female,,9/25/2007,,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L213,4/11/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11JM16425A,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,,2/24/2012,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L214,5/9/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,7FM05246,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,8/5/2008,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L215,6/1/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,12em15634,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,6/28/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L216,6/1/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,3DM12401,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,95,2/18/2015,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L217,6/7/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,14KM05805B,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,48,Male,,5/26/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L218,6/13/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09EM08317,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,113,4/12/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L219,7/1/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08DM24947B,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,,6/7/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L220,7/19/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08fm22589,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Male,,12/15/2008,,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L221,8/1/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09am02678,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,6/10/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L222,9/2/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12fm05399,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,80,Female,30,11/29/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L223,9/12/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08CM00487,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,88,7/14/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L224,9/20/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,8KM05052,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Periprosthetic Fracture, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Male,81,1/5/2010,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L225,11/9/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,4CM17772C,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,2/18/2015,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L226,11/10/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09mm08423,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Stiffness, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,54,Female,,5/13/2010,,E1616;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L227,11/14/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,9LM02193,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,7/19/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L228,11/14/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,14bm02029,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,,11/20/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L229,11/21/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,12HM00973,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Male,,1/15/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L230,11/30/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,11CM12573,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,,10/3/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L231,1/9/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,13MM00213,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,46,Female,,6/27/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L232,1/16/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09bm04564,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,11/26/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L233,1/25/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,0AM06743,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,90,4/27/2010,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L234,2/7/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11EM00688,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,11/7/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L235,2/15/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,13MM00206,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,92,2/12/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L236,3/1/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,09MM02046,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,11/25/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L237,3/7/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09gm05671,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Female,,5/8/2010,,E1615;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L238,3/22/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11LM10288,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,7/16/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L239,3/29/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12hm09735,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Male,,4/27/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L240,4/24/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,12mm12847,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,,4/13/2013,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L241,5/4/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,3DM16595,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,83,2/12/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L242,6/20/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,15lm04952,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,116,8/4/2016,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L243,6/26/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12EM1175,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,66,4/24/2013,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L244,7/3/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,2AM09480,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,9/3/2015,,E1614;E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L245,7/10/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,07GM11725,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,1/8/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L246,7/18/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,0CM14452,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Male,87,8/19/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L247,9/8/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,08DM07886,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Male,,9/12/2008,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L248,9/19/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08cm03932,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Male,,11/30/2009,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L249,10/16/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14cm07837,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,1/14/2016,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L250,11/7/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,9EM12052,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,10/12/2010,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L251,11/22/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,4AM19851,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,11/26/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L252,12/15/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10fm03870,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Male,,10/28/2011,12/15/2017,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L253,1/15/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,2HM00971,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,4/12/2013,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L254,2/21/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10JM05004,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,11/4/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L255,3/22/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,214lm09867,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Female,,2/4/2016,,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L256,4/16/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13dm17487,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,12/4/2013,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L257,5/4/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13gm10952,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,95,4/25/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L258,5/18/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08CM14846,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Male,,9/12/2008,,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L259,6/14/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,15BM12178,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,41,Female,,9/24/2015,6/14/2018,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L260,6/14/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15km13579,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,44,Female,80,7/28/2016,6/14/2018,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L261,7/4/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,14KM09522A,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,7/30/2015,7/4/2018,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L262,7/10/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11JM15316,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Component Dissociation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,3/3/2014,,E2401,F1905,A040503;A051201,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L263,7/19/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,09bm,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,,9/2/2010,7/19/2018,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L264,7/20/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,13dm01635,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,1/24/2017,7/20/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L265,7/23/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,12HM08915,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,,5/1/2015,7/23/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L266,7/25/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM17671,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,9/10/2007,7/25/2018,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L267,7/30/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,15EM15786,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Instability, Wear of Polyethylene Component, Component Dissociation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,53,Female,,10/26/2015,,E1614;E1615,F1905,A24;A040503;A051201,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L268,8/2/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07HM12248,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,75,2/10/2010,8/2/2018,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L269,8/13/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15dm19859b,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,7/31/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L270,8/28/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,15M,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,6/13/2017,8/28/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L271,9/10/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,13EM11224,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,11/12/2013,9/10/2018,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L272,9/28/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06gm07919,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Female,,2/8/2007,9/28/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L273,10/4/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11HM17116,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,67,2/16/2012,10/4/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L274,10/12/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08EM10533,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Malalignment, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Previous Trauma.,56,Male,,2/26/2009,10/12/2018,E2308;E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L275,10/22/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11EM03509,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,91,1/26/2012,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L276,11/10/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,13EM18480,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,90,3/21/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L277,11/20/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,12JM04001,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,2/15/2013,11/20/2018,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L278,11/29/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,15mm04053,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,,7/26/2017,11/29/2018,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L279,11/30/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07JM14573,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Tibia.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,,7/11/2008,11/30/2018,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L280,12/3/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15KM13579,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Male,83,1/20/2017,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L281,12/11/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12fm00166a,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Female,83,3/22/2013,12/11/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L282,12/14/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08JM17331,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Male,83,8/20/2009,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L283,1/3/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,16DM01994,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Male,90,10/17/2017,1/3/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L284,2/8/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15LM02652,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Stiffness.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,,5/30/2017,2/8/2019,E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L285,2/11/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,15MM11006,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,89,1/18/2017,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L286,3/11/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,16E,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,4/25/2017,3/11/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L287,3/19/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10FM08916,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,2/3/2011,3/19/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L288,3/21/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08bm11538,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,70,Male,,6/28/2009,3/21/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L289,4/8/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09BM17652,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,6/10/2010,4/8/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L290,4/16/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09AM05830,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,7/15/2009,4/16/2019,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L291,4/29/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10cm04365,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,6/13/2011,4/29/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L292,5/13/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07dm04413,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Male,,12/13/2010,5/13/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L293,5/14/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,14cm19149,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,9/14/2015,5/14/2019,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L294,5/18/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,16GM18352,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Male,90,2/1/2018,5/18/2019,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L295,5/28/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,0AM06743,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,5/31/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L296,5/31/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,11LM10770,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Male,,10/12/2012,5/31/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L297,6/5/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,10HM01542,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,,11/29/2011,6/5/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L298,6/10/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,12FM07727,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Male,,11/12/2012,6/10/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L299,6/20/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,1AM03657,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Male,,5/19/2011,6/20/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L300,7/3/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,17KM06690,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,73,3/19/2018,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L301,7/9/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08km03748,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,8/11/2009,7/9/2019,E1906;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L302,7/11/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,15MM04036,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Unexplained Pain, Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,45,Female,,6/29/2017,7/11/2019,E1615;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L303,7/30/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11em,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,45,1/9/2012,7/30/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L304,8/2/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,12EM18040,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,9/12/2014,8/2/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L305,8/5/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14HM00733,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,83,7/28/2015,8/5/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L306,8/6/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,2MM12847,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,4/12/2013,8/6/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L307,9/6/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,2HM03797,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,5/17/2013,9/6/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L308,9/7/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,16em11704,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,,3/30/2017,9/7/2019,E2401;E2308,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L309,9/20/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,17HM10512,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Male,,6/8/2018,9/20/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L310,9/26/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,16EM11703,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,7/19/2017,9/26/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L311,10/11/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,14am09405,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,46,Female,,1/27/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L312,10/14/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09HM05346,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,3/30/2010,10/14/2019,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L313,10/16/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11LM11941,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,79,2/28/2012,10/16/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L314,10/18/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12bm18820,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Tibia.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,10/19/2012,10/18/2019,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L315,10/18/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,14LM06872,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,8/24/2015,10/18/2019,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L316,10/25/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,5FM05151,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,2/10/2016,10/25/2019,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L317,11/12/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08BMO6523,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,87,3/16/2012,11/12/2019,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L318,11/14/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,6GM07921,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,61,2/23/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L319,11/23/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,12FM14426,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,2/25/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L320,11/27/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08HM14063,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,89,4/15/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L321,11/28/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,17KM01230,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,6/11/2018,11/28/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L322,12/11/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,10HM11943,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,,4/5/2011,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L323,12/12/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,07EM01781,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,11/13/2008,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L324,1/3/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,18DM12269,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection, Stiffness.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,2/14/2019,1/3/2020,E1906;E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L325,1/11/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,6GM07112,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,84,Female,74,3/10/2009,1/11/2020,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L326,1/14/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07BM10064,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,70,9/3/2007,1/14/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L327,1/15/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,7GM11819,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,,8/1/2012,1/15/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L328,2/1/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14am19851,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,11/12/2015,2/1/2020,E1614;E2308,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L329,2/12/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,06GM07920,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,41,Female,81,1/31/2007,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L330,2/12/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,15bm13451,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,84,11/10/2015,2/12/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L331,2/21/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11gm10423,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,11/30/2011,2/21/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L332,3/3/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,12FM16241,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,90,12/31/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L333,7/30/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,18CM21009,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Stiffness.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,10/24/2018,,E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L334,9/18/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,11hm11119,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,7/1/2013,9/18/2020,E161201;E2330,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L335,9/28/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12KM05000,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,96,11/27/2013,9/28/2020,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L336,10/9/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10CM13502,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Wear of Polyethylene Component, Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,89,9/10/2011,10/9/2020,E1615;E2330;E1602,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L337,10/23/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14dm06808,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,8/14/2015,10/23/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L338,11/16/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,18BM20319,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Male,86,1/7/2020,11/16/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L339,12/7/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,15LM00601,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,10/24/2016,12/7/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L340,12/7/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,18DM06836,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,72,11/5/2018,12/7/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L341,12/7/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,17CM20478,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,3/25/2019,12/7/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L342,12/9/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,18gm10569a,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Component Dissociation, Unexplained Pain, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,48,Female,,1/7/2019,,E2330;E161201,F1905,A051201;A24;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L343,12/17/2020,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,15MM04044,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,4/6/2017,12/17/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L344,1/16/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14BM02027,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,81,4/2/2015,1/16/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L345,3/24/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,17AM113682,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,10/26/2017,3/24/2021,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L346,3/26/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,06FM09826,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Male,,3/5/2007,3/26/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L347,4/7/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,7GM05117,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,5/16/2008,4/7/2021,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L348,5/4/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,20KM20244,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Female,52,1/12/2021,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L349,5/5/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,3HM04083,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,91,11/21/2013,5/5/2021,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L350,5/13/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15EM18606,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,83,1/14/2020,5/13/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L351,5/17/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09cm09203,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,3/30/2010,5/17/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L352,5/18/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,17AM13679,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,,2/13/2018,5/18/2021,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L353,5/21/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,15JM20216,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,6/30/2016,5/21/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L354,6/16/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,17CM12976,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Male,,10/25/2017,6/16/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L355,6/23/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10cm09368,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,87,Female,,5/8/2013,6/23/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L356,7/7/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,9HM06820,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Female,101,11/27/2010,7/7/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L357,7/12/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,18dm19783,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Male,,4/15/2019,7/12/2021,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L358,7/21/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10JM17212,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,52,3/23/2011,7/21/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L359,7/26/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,07EM017181,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Male,108,2/6/2008,7/26/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L360,7/27/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),MEDIUM PATELLA FEM IMPLANT RT,71932207,05KM03805,71932207,,,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,,10/21/2005,7/27/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L361,8/5/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,17FM12820,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Component Dissociation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Male,92,10/18/2018,8/5/2021,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L362,8/16/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07em15509,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,91,Male,,7/1/2010,8/16/2021,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L363,8/19/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08GM15162A,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Male,123,8/21/2009,8/19/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L364,8/31/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,18HM14426,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,2/18/2019,8/31/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L365,8/31/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,19KM13912,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,97,4/23/2021,8/31/2021,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L366,9/10/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,09BM07505,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Aseptic loosening Tibia.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,,8/3/2010,9/10/2021,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L367,9/22/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11CM05212,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,,6/9/2011,9/22/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L368,9/23/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,18bm03362,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,63,3/4/2019,9/23/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L369,9/27/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06DM08704,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: other-unspecified reasons (please specify), Trochlear dysplasia.",54,Female,,7/3/2006,9/27/2021,E1615;E2308,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L370,11/16/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,14am19852,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Male,93,11/19/2015,11/16/2021,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L371,12/13/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,20EM09799,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,78,11/3/2020,12/13/2021,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L372,12/14/2021,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,19em03560,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Male,89,12/17/2020,12/14/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L373,1/27/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09cm05015,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,79,Female,69,3/13/2012,1/27/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L374,1/31/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,16DM01988,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,10/27/2017,1/31/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L375,1/31/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,1LM06125,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,,10/27/2017,1/31/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L376,2/11/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,09AM05830,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Female,63,10/20/2009,2/11/2022,E2401;E2308,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L377,2/15/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12gm08062,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Female,,1/20/2014,2/15/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L378,2/21/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14BM02027,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,72,1/30/2015,2/21/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L379,2/24/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,18cm21007,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,3/4/2019,2/24/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L380,3/8/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,21FM18017,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,58,Male,70,10/26/2021,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L381,3/24/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,17AM13679,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,60,3/27/2018,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L382,4/26/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08em05928,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,2/4/2010,4/26/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L383,5/3/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,19LM12541,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Male,,4/15/2021,5/3/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L384,5/12/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,16gm18352,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Male,98,1/8/2018,5/12/2022,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L385,5/16/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,18em11593a,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Malalignment, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,1/28/2019,,E2330;E2308;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L386,5/20/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,15hm18413,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,,1/18/2016,5/20/2022,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L387,5/20/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,18dm06840,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,107,10/10/2018,5/20/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L388,5/23/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,07am09279,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,3/31/2008,5/23/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L389,5/25/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10CM18630A,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,4/30/2012,5/25/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L390,6/22/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,18hm04189,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,,9/18/2019,6/22/2022,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L391,7/5/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,18gm18268,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Female,,2/18/2019,7/5/2022,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L392,7/6/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,17km01231a,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,90,7/11/2018,7/6/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L393,8/1/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,19EM03559,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,48,Male,,3/6/2020,8/1/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L394,8/8/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,8KM00451,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Female,,4/21/2009,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L395,8/31/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,3MM07427,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,101,7/16/2014,8/31/2022,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L396,9/6/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07EM06160,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,1/31/2008,9/6/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L397,9/8/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,18GM15604,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: other-unspecified reasons Inflammatory Arthropathy, Osteoarthritis.",58,Female,,12/1/2018,9/8/2022,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L398,9/20/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11EM00685,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,,11/15/2011,9/20/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L399,9/27/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07GM00419,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Male,,4/29/2008,9/27/2022,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L400,9/27/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,18mm05456a,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Male,89,12/17/2020,9/27/2022,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L401,10/5/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09LM10684,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Female,,6/21/2010,10/5/2022,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L402,10/10/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,12cm18827,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,10/21/2014,10/10/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L403,10/20/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12am09481,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,78,11/2/2012,10/20/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L404,11/12/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,17am13683,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,8/7/2017,11/12/2022,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L405,11/17/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM07016,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,83,6/28/2007,11/17/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L406,11/18/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,05km01957,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,107,7/12/2011,11/18/2022,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L407,11/21/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09gm05671,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,82,4/8/2011,11/21/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L408,11/26/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,15LM04950,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,84,Female,,2/3/2017,11/26/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L409,12/13/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,19KM13912,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,12/2/2019,12/13/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L410,12/14/2022,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,19AM04526,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,79,9/21/2021,12/14/2022,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L411,1/30/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,18DM06836,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,,9/5/2018,1/30/2023,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L412,2/8/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,06EM00801,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Male,97,6/6/2007,2/8/2023,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L413,2/10/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,21CM02106,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,100,2/4/2022,2/10/2023,E1906;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L414,3/15/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,17MM02303,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Male,105,4/23/2018,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L415,3/20/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13GM06864,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation, Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,2/25/2014,3/20/2023,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L416,3/22/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,2EM11177,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Female,88,6/5/2013,3/22/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L417,3/29/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08dm06600,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,,12/17/2009,3/29/2023,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L418,4/21/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,15LM04936,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,90,3/14/2017,4/21/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L419,5/2/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,16dm18235,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,81,2/14/2017,5/2/2023,E161201;E2330,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L420,5/2/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,17FM12821,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,94,7/9/2019,5/2/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L421,5/9/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,07EM02414,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Male,115,5/16/2008,5/9/2023,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L422,6/8/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,8CM19370,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,79,Female,,8/29/2008,6/8/2023,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L423,6/14/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07jm01419a,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Periprosthetic Fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,9/28/2012,6/14/2023,E2127,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L424,6/22/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,18DM06845,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,98,11/15/2018,6/22/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L425,7/11/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10JM14278,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,3/26/2011,7/11/2023,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L426,7/11/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12EMo1451,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Female,,8/9/2012,7/11/2023,E161201,F1905,A040503;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L427,7/18/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10HM11942,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Periprosthetic Fracture, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,96,3/24/2011,7/18/2023,E2127;E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L428,7/19/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,19LM12528,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,47,Female,,10/26/2020,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L429,8/8/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08MM16421A,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,124,10/30/2009,8/8/2023,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L430,9/4/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,18LM16225,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Male,,4/28/2021,9/4/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L431,9/8/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08DM10118,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Aseptic loosening Patella, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Male,,4/27/2010,,E161201;E1602,F1905,A040503;A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L432,9/11/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11EM00683,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,6/18/2012,9/11/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L433,9/19/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,3MM15034,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,83,Female,80,4/2/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L434,10/9/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06CM06335,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,60,6/28/2006,10/9/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L435,10/12/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,17FM12813,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,,4/30/2018,10/12/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L436,10/24/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11FM04674,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,4/30/2012,10/24/2023,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L437,11/20/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14jmo8816,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,6/26/2015,11/20/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L438,11/27/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,22FM10019,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability, Implant fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,35,Female,,9/13/2022,11/27/2023,E1615,F1905,A24;A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L439,12/4/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,14MM18662A,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,55,Female,,4/22/2016,12/4/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L440,12/5/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12BM18814,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Implant fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,70,Female,,6/29/2012,12/5/2023,E2401,F1905,A040503;A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L441,1/12/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12mm03116,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,106,9/27/2013,1/12/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L442,1/16/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,19BM22584,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Male,126,10/23/2019,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L443,1/18/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08CM20547,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: Avascular Necrosis (AVN), Osteoarthritis.",50,Female,,12/8/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L444,1/22/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13FM09492,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,54,Female,88,12/2/2013,1/22/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L445,1/24/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10JM04077,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Female,,9/1/2011,1/24/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L446,1/24/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,15MM04075,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Male,86,10/31/2016,1/24/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L447,2/12/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08mm13132,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Female,,1/18/2012,2/12/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L448,2/28/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,10jm05005,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Male,,1/17/2015,2/28/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L449,2/28/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,18GM15604,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,92,12/7/2018,2/28/2024,E161201;E1614,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L450,3/7/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07KM09588,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,12/22/2011,3/7/2024,E2330;E161201,F1905,A24;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L451,3/12/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,15MM04073,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,53,Female,74,7/21/2016,3/12/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L452,3/12/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,23gm13851,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Other-unspecified reasons.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,,11/9/2023,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L453,3/25/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,08em19106,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,9/15/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L454,4/8/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,12bm03670,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,,11/19/2012,4/8/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L455,6/5/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,17HM10515A,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Tibia.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Male,75,7/29/2021,6/5/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L456,6/21/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,08fm22589,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Male,,2/11/2014,6/21/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L457,6/25/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,7DM18211,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,,7/31/2012,6/25/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L458,6/25/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,21lm07907,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,44,Female,,5/16/2023,6/25/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L459,7/10/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,13fm19413,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,65,Female,,6/10/2015,7/10/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L460,7/16/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,07DM00524,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,80,11/13/2007,7/16/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L461,7/30/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06cm06335a,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,79,1/3/2007,7/30/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L462,7/31/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,10JM14277,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,4/25/2012,7/31/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L463,8/8/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,16AM01180,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,124,6/9/2017,8/8/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L464,8/12/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,09BM15449,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,,9/17/2009,8/12/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L465,8/13/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11LM10769,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,51,Female,,4/16/2012,8/13/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L466,8/13/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,21FM08423,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,73,9/15/2021,8/13/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L467,8/22/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,22KM03879,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,,1/19/2023,8/22/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L468,9/3/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07bm14342,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ","Indication for Primary Procedure: Osteoarthritis, trochlear dysplesia.",54,Female,,10/12/2007,9/3/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L469,9/10/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,18hm04190,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,3/13/2019,9/10/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L470,9/16/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,13cm16928,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,44,Female,,10/11/2013,9/16/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L471,9/18/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09am02678,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,,12/17/2009,9/18/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L472,9/30/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,07FM00204,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Male,125,1/31/2015,9/30/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L473,10/3/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,6FM19455,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,8/15/2007,10/3/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L474,10/14/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10gm02014,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Male,76,10/12/2011,10/14/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L475,10/24/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,16LM14595,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,43,Female,,11/24/2022,10/24/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L476,10/28/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10GM07899,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Periprosthetic Fracture, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,68,Female,,2/22/2011,10/28/2024,E2127;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L477,11/6/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,07GM11819,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,67,Female,,8/21/2009,11/6/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L478,11/11/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08DM05474,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,5/7/2009,11/11/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L479,11/12/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,10JM07181,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,73,4/2/2011,11/12/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L480,11/18/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,17HM10514,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,49,Female,,9/11/2018,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L481,11/19/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,07dm21588,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Female,,5/1/2008,11/19/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L482,11/20/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,10em08153,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Male,,11/2/2011,11/20/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L483,11/25/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,09bm07505,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,70,1/13/2011,11/25/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L484,11/29/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,13cm12580,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,59,Female,,2/28/2014,11/29/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L485,12/3/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,18GM21960,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Infection.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Male,90,4/10/2019,12/3/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L486,12/5/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,13am06892,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,73,Male,,1/16/2014,12/5/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L487,12/7/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,07mm13613,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,70,4/19/2008,12/7/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L488,12/11/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,8FM00085,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,64,Female,,7/10/2009,12/11/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L489,12/11/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,18CM03630b,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Malalignment.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,76,Female,65,3/25/2019,12/11/2024,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L490,12/23/2024,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,12bm17323,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,11/14/2012,12/23/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L491,1/3/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11AM02641,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Femur, Aseptic loosening Tibia, Lysis Femur, Lysis Tibia, Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: other-unspecified reasons.,66,Female,,4/20/2012,1/3/2025,E161201;E1627;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L492,1/6/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,06cm08094,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Male,,7/8/2013,1/6/2025,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L493,1/10/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,10fm08916,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,77,Female,,1/21/2011,1/10/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L494,1/24/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,09AM15964,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,,8/31/2010,1/24/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L495,1/27/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,19bm17136,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,46,Female,105,10/4/2019,1/27/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L496,1/28/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,21cm04347,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,60,Female,,9/16/2021,1/28/2025,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L497,1/30/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,06KM00547,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,62,Female,,11/2/2007,1/30/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L498,1/31/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,14LM09867,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,50,Female,,5/12/2015,1/31/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L499,2/4/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,17AM13679,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Aseptic loosening Patella, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,75,Female,,12/14/2017,2/4/2025,E161201;E1602,F1905,A040503;A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L500,2/6/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11em03510,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,66,Female,,6/1/2012,2/6/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L501,2/13/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07gm07961,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,69,Female,76,1/23/2008,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L502,2/26/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,11cm06236,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,79,Female,96,10/26/2011,2/26/2025,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L503,3/8/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,07mm07008,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,71,Female,52,8/24/2011,3/8/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L504,3/17/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,17FM09016,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,81,Female,,2/5/2018,3/17/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L505,4/3/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,06gm09555,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,63,Female,,5/10/2007,4/3/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L506,4/6/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,10MM01816,71461017,,03596010544247,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,56,Male,100,4/2/2012,4/6/2025,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L507,4/7/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,08HM08683,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,57,Female,,11/5/2009,4/7/2025,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L508,4/14/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,11jm02814,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,80,Female,,8/29/2012,4/14/2025,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L509,4/24/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07GM06892,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,74,Female,,10/17/2007,,E161201,F1905,A040503;A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L510,4/28/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,18JM17327,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,52,Female,84,9/16/2019,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L511,5/2/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,08LM12915,71461016,,03596010544230,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,72,Female,78,10/7/2013,5/2/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L512,5/12/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,09lm02192,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Aseptic loosening Patella.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,61,Female,,1/7/2011,5/12/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L513,5/13/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,11mm00533,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,78,Female,,5/21/2012,5/13/2025,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287076-1-L514,5/16/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,8DM19279,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later revised due to: Wear of Polyethylene Component, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of two thousand eight hundred and ninety-four (2,894) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 20-May-2025, using a JOURNEY PFJ replacement. From these, five hundred fourteen (514) knees were later revised due to the following complications: two hundred and eighty-four (284) knees due to progressive arthritis remaining, one hundred (100) knees due to pain, sixty-eight (68) knees due to wear of the polyethylene component, thirty (30) knees due to malalignment, twenty-eight (28) knees due to aseptic loosening of the patella, twenty-one (21) knees due to instability, eighteen (18) knees due to dislocation or subluxation, thirteen (13) knees due to aseptic loosening of the femur, thirteen (13) knees due to infection, ten (10) knees due to stiffness, eight (8) knees due to component dissociation, eight (8) knees due to periprosthetic fracture, five (5) knees due to aseptic loosening of the tibia, four (4) knees due to implant fracture, three (3) knees due to lysis of the tibia, one (1) knee due to lysis of the femur, and forty-nine (49) knees due to other-unspecified reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 13-Oct-2005 and 20-May-2025 in United Kingdom. ;;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 two thousand eight hundred and ninety-four (2,894) procedures with JOURNEY PFJ have been performed in the United Kingdom between 13-Oct-2005 and 20-May-2025. The cumulative revision rates of JOURNEY PFJ implant was significantly higher than the class device across 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.87% (1.42%-2.45%) vs 1.01% (0.87%-1.16%) of the class. ;;-At 3rd postoperative year: 7.11% (6.18%-8.18%) vs 5.39% (5.05%-5.74%) of the class. ;;-At 5th postoperative year: 11.42% (10.21%-12.76%) vs 8.85% (8.41%-9.30%) of the class. ;;-At 10th postoperative year: 19.64% (17.95%-21.47%) vs 16.90% (16.25%-17.58%) of the class. ;;-At 15th postoperative year: 28.72% (26.25%-31.37%) vs 24.39% (23.42%-25.40%) of the class. ;;;The most common reason for revision is progressive arthritis (9.8%), which is a common reason for revision after patellofemoral implantations and may be related to a number of factors beyond the performance of the device. Additionally, a lower implantation age (58.5 years), affords more patient lifespan after implantation and subsequently greater risk for patient-related reasons for revision resulting activities of daily living. ;;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. ",Indication for Primary Procedure: Osteoarthritis.,86,Female,,9/3/2008,5/16/2025,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L1,2/27/2008,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,06HM14476,71461011,,03596010573315,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Malalignment.,58,Female,78,11/3/2007,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L2,5/29/2012,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11CM16425,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Unexplained Pain.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Other-unspecified.,48,Female,,10/4/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L3,12/14/2016,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,4CM19144,71461010,,03596010573308,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Aseptic loosening Patella.,70,Female,,3/22/2016,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L4,6/14/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,15am0780,71461013,,03596010544209,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Progressive Athritis.,63,Female,73,10/8/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L5,6/27/2017,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,16AM01179,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Instability.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Other-unspecified.,69,Female,,11/22/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L6,10/29/2018,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,14lm09871,71461015,,03596010544223,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Infection, Lysis Femur, Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Other-unspecified.,72,Male,,10/19/2015,10/29/2018,E1906;E1627,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L7,6/18/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07em07695,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Malalignment.,64,Female,,2/22/2008,6/18/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L8,12/16/2019,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,4GM1979,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Wear of Polyethylene Component, Unexplained Pain, ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ","Indication for revision procedure: Unexplained Pain, other-unspecified.",52,Female,,11/30/2015,12/16/2019,E2330;E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L9,7/5/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,22EM05643,71461014,,03596010544216,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:Wear of Polyethylene Component.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Progressive Athritis.,60,Female,100,10/7/2022,7/5/2023,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L10,10/19/2023,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11AM17181,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Malalignment.,69,Female,,7/8/2011,10/19/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287080-1-L11,5/7/2025,10/14/2025,7/1/2025,JOURNEY PATELLOFEMORAL JOINT (PFJ),JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,18cm03627a,71461012,,03596010544193,K051086,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision of patellofemoral knee arthroplasty between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, one (1) knee was later re-revised due to:ProgressiveAthritis.","Reporting Quarter: 3 (July 1 - September 30, 2025) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of forty-four (44) knees underwent revision patellofemoral knee arthroplasty procedures between 3-Nov-2007 and 24-Mar-2025, using a JOURNEY PFJ replacement. From these, eleven (11) knees were later re-revised due to the following complications: five (5) knees due to progressive arthritis remaining, three (3) knees due to wear of the polyethylene component, two (2) knees due to dislocation or subluxation, two (2) knees due to pain, one (1) knee due to infection, one (1) knee due to instability, and one (1) knee due to lysis of the femur. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 3-Nov-2007 and 24-Mar-2025 in United Kingdom. ;;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 forty-four (44) procedures with JOURNEY PFJ have been performed in the United Kingdom between 3-Nov-2007 and 24-Mar-2025. The cumulative re-revision rates for the JOURNEY PFJ implant were significantly higher than the class device across 15 years of follow-up, based on the non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 11.9% (5.14%-26.27%) vs 1.39% (1.0%-1.92%) of the class. ;;-At 3rd postoperative year: 17.27% (8.6%-32.95%) vs 4.37% (3.62%-5.29%) of the class. ;;-At 5th postoperative year: 20.58% (10.76%-37.28%) vs 6.48% (5.52%-7.60%) of the class. ;;-At 10th postoperative year: 25.00% (13.48%-43.52%) vs 9.62% (8.29%-11.15%) of the class. ;;-At 15th postoperative year: 51.78% (25.22%-83.97%) vs 14.76% (11.92%-18.21%) of the class. ;;The cumulative re-revision rates for the subject device may have a low statistical reliability due to the low number of implantations for the subject device. Also, the mean age of implantation during revision procedures was 61.2 years which allows for patient-related factors such as an active lifestyle to contribute to reasons for revision such as implant wearing. ;;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. ",Indication for revision procedure: Progressive Athritis.,62,Female,,11/1/2018,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY PATELLOFEMORAL JOINT (PFJ) REPLACEMENT PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT (PFJ) OXINIUM COMPONENTS: IMPLANTED IN A TOTAL OF TWO THOUSAND EIGHT HUNDRED AND NINETY-FOUR (2,894) KNEES BETWEEN 13-OCT-2005 AND 20-MAY-2025. FROM THESE, FIVE HUNDRED FOURTEEN (514) KNEES WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO HUNDRED AND EIGHTY-FOUR (284) KNEES DUE TO PROGRESSIVE ARTHRITIS REMAINING, ONE HUNDRED (100) KNEES DUE TO PAIN, SIXTY-EIGHT (68) KNEES DUE TO WEAR OF THE POLYETHYLENE COMPONENT, THIRTY (30) KNEES DUE TO MALALIGNMENT, TWENTY-EIGHT (28) KNEES DUE TO ASEPTIC LOOSENING OF THE PATELLA, TWENTY-ONE (21) KNEES DUE TO INSTABILITY, EIGHTEEN (18) KNEES DUE TO DISLOCATION OR SUBLUXATION, THIRTEEN (13) KNEES DUE TO ASEPTIC LOOSENING OF THE FEMUR, THIRTEEN (13) KNEES DUE TO INFECTION, TEN (10) KNEES DUE TO STIFFNESS, EIGHT (8) KNEES DUE TO COMPONENT DISSOCIATION, EIGHT (8) KNEES DUE TO PERIPROSTHETIC FRACTURE, FIVE (5) KNEES DUE TO ASEPTIC LOOSENING OF THE TIBIA, FOUR (4) KNEES DUE TO IMPLANT FRACTURE, THREE (3) KNEES DUE TO LYSIS OF THE TIBIA, ONE (1) KNEE DUE TO LYSIS OF THE FEMUR, AND FORTY-NINE (49) KNEES DUE TO OTHER-UNSPECIFIED REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. 2. REVISION PATELLOFEMORAL JOINT (PFJ) REPLACEMENT PROCEDURES: - JOURNEY PATELLOFEMORAL JOINT (PFJ) OXINIUM COMPONENTS: IMPLANTED IN A TOTAL OF FORTY-FOUR (44) KNEES BETWEEN 3-NOV-2007 AND 24-MAR-2025. FROM THESE, ELEVEN (11) KNEES WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: FIVE (5) KNEES DUE TO PROGRESSIVE ARTHRITIS REMAINING, THREE (3) KNEES DUE TO WEAR OF THE POLYETHYLENE COMPONENT, TWO (2) KNEES DUE TO DISLOCATION OR SUBLUXATION, TWO (2) KNEES DUE TO PAIN, ONE (1) KNEE DUE TO INFECTION, ONE (1) KNEE DUE TO INSTABILITY, AND ONE (1) KNEE DUE TO LYSIS OF THE FEMUR. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF FIVE HUNDRED AND FOURTEEN (514) REVISIONS AND ELEVEN (11) RE-REVISIONS HAVE BEEN REPORTED IN THE NJR FOR THE JOURNEY PATELLOFEMORAL JOINT (PFJ) OXINIUM COMPONENT, RESULTING IN A TOTAL OF 525 EVENTS SUMMARIZED THROUGH THIS 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2018922		PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	KRR	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR	Unknown

Terms

Patient problem · 11

Arthritis Aseptic loosening Deformity/ Disfigurement Insufficient Information Joint Dislocation Joint Laxity Loss of Range of Motion Osteolysis Pain Periprosthetic fracture Unspecified Infection

Product problems · 5

Adverse Event Without Identified Device or Use Problem Device Dislodged or Dislocated Fracture Loosening of Implant Not Related to Bone-Ingrowth Material Erosion

Source type · 1

Other

Type of report · 2

Followup Initial submission