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

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00287076-1-L515,11/14/2023,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,15BN13452,71461015,,03596010544223,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Aseptic loosening Femur, Aseptic loosening Tibia, Aseptic loosening Patella, Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with 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.,55,Female,,9/8/2015,11/14/2023,E1602;E161201,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L516,5/16/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,7HM25010,71461016,,03596010544230,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,2/15/2010,5/16/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L517,5/21/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,07GM16534,71461017,,03596010544247,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,8/21/2009,5/21/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L518,5/30/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,17EM02066,71461015,,03596010544223,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component, Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,2/5/2018,5/30/2025,E1602;E2401,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L519,6/2/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,13lm05644,71461017,,03596010544247,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,8/5/2019,6/2/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L520,6/16/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,24AM16254,71461014,,03596010544216,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,8/19/2024,6/16/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L521,6/19/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,15mm0409,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Aseptic loosening Patella.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,9/20/2016,6/19/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L522,7/4/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,11CM05210B,71461012,,03596010544193,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component, Malalignment.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,6/1/2012,7/4/2025,E2308;E2401,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L523,7/7/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,14km03844,71461012,,03596010544193,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,10/16/2015,7/7/2025,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L524,8/7/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,08jm17331,71461015,,03596010544223,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,4/3/2009,8/7/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L525,8/13/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,17FM09016,71461012,,03596010544193,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,11/9/2017,8/13/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L526,8/18/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,13KM14140,71461012,,03596010544193,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,90,2/12/2015,8/18/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L527,8/22/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,24fm3312,71461017,,03596010544247,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,12/17/2024,8/22/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L528,9/13/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,06EM17419,71461014,,03596010544216,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component, Implant fracture, Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,2/1/2008,9/13/2025,E1602;E2401,F1905,A040101;A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L529,9/25/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,07dm16702,71461014,,03596010544216,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,1/4/2008,9/25/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L530,9/30/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,17am20628,71461014,,03596010544216,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,Male,,10/18/2017,9/30/2025,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L531,10/4/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,25DM04624,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Periprosthetic Fracture, Implant fracture.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,8/8/2025,10/4/2025,E2127;E2401,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L532,10/6/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,23HM07575,71461010,,03596010573308,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Aseptic loosening Femur.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,71,4/29/2024,10/6/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L533,10/9/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,0FM01872,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,10/12/2010,10/9/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L534,10/15/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,10AM14912A,71461015,,03596010544223,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,70,7/26/2010,10/15/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L535,11/5/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,11em03507,71461011,,03596010573315,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,1/20/2012,11/5/2025,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L536,12/1/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,17dm02493,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Wear of Polyethylene Component, Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,78,11/20/2017,12/1/2025,E1602;E2401,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L537,12/11/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,13fm19416a,71461017,,03596010544247,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,6/30/2016,12/11/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L538,12/15/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,14BM08126,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,10/13/2015,12/15/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L539,12/17/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,12gm13034,71461014,,03596010544216,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,8/24/2013,12/17/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L540,12/31/2025,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,13AM03072,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,5/7/2013,12/31/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L541,1/12/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,12fm19460,71461011,,03596010573315,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,10/17/2013,1/12/2026,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L542,1/21/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,10FM00389,71461014,,03596010544216,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,11/16/2010,1/21/2026,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L543,2/3/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,08GM06503,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,68,3/9/2009,2/3/2026,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L544,2/20/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,24jm07707,71461012,,03596010544193,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Unexplained Pain.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,7/16/2025,2/20/2026,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L545,3/13/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,14cm19144,71461010,,03596010573308,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,6/6/2015,3/13/2026,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L546,3/13/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,18CM03642,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,1/11/2019,3/13/2026,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L547,4/2/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,06mm05524,71461011,,03596010573315,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Periprosthetic Fracture, Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,11/15/2007,4/2/2026,E1602;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287076-1-L548,4/8/2026,7/15/2026,6/3/2026,JOURNEY Patellofemoral Joint (PFJ) Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,07DM17671,71461013,,03596010544209,K051086,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 using a JOURNEY PFJ System . These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, one (1) knee required revision surgery due to Progressive Athritis.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty between 13-Oct-2005 and 28-Apr-2026 in which a JOURNEY PFJ System was implanted. These include two thousand nine hundred and eighty-two (2,982) systems with a GENESIS II Patellar Implant, and one hundred and seventy (170) systems with off-label patellar implants. Of these, five hundred and forty-eight (548) knees required revision due to the following reasons: three hundred ten (310) knees due to progressive arthritis remaining, one hundred one (101) due to pain, seventy-five (75) due to wear of polyethylene component, thirty-one (31) due to malalignment, thirty (30) due to aseptic loosening of the patella, twenty-one (21) due to instability, eighteen (18) due to dislocation/subluxation, fifteen (15) due to aseptic loosening of the femur, thirteen (13) due to infection, ten (10) due to stiffness, eight (8) due to component dissociation, ten (10) due to periprosthetic fracture, six (6) due to aseptic loosening of the tibia, six (6) due to implant fracture, three (3) due to lysis of the tibia, one (1) due to lysis of the femur, and forty-nine (49) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-Oct-2005 and 28-Apr-2026 in United Kingdom;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. ;According to this registry report, a total of three thousand one hundred and fifty-two (3,152) knees underwent primary patellofemoral knee arthroplasty in which a JOURNEY PFJ System was implanted in United Kingdom between 13-Oct-2005 and 28-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.85% (1.41%-2.42%) vs 0.96% (0.83%-1.11%) of the class;-At 3rd postoperative year: 6.45% (5.56%-7.47%) vs 5.25% (4.93%-5.59%) of the class;-At 5th postoperative year: 10.58% (9.42%-11.89%) vs 8.65% (8.23%-9.09%) of the class;-At 10th postoperative year: 18.38% (16.74%-20.16%) vs 16.75% (16.12%-17.40%) of the class;By observing the cumulative revision rates above, at the 3rd and 10th postoperative years, there is no statistically significant difference between the revision rates of the study device and the class, as determined by overlapping 95% confidence intervals.;However, there is a statistically significant difference between the revision rates of the study device and the class at the 1st and 5th postoperative years, as determined by non-overlapping 95% confidence intervals, with the JOURNEY PFJ System demonstrating higher revision rates than the class. The most common reason for revision is progressive osteoarthritis (9.66%), which is 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 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.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our 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,,12/13/2007,4/8/2026,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2026) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN KNEE ARTHROPLASTY: 1. PRIMARY PATELLOFEMORAL KNEE ARTHROPLASTY JOURNEY PFJ SYSTEM: IMPLANTED IN A TOTAL OF THREE THOUSAND ONE HUNDRED AND FIFTY-TWO (3,152) KNEES BETWEEN 13-OCT-2005 AND 28-APR-2026. THESE INCLUDE TWO THOUSAND NINE HUNDRED AND EIGHTY-TWO (2,982) SYSTEMS WITH A GENESIS II PATELLAR IMPLANT, AND ONE HUNDRED AND SEVENTY (170) SYSTEMS WITH OFF-LABEL PATELLAR IMPLANTS. OF THESE, FIVE HUNDRED AND FORTY-EIGHT (548) KNEES REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE HUNDRED TEN (310) KNEES DUE TO PROGRESSIVE ARTHRITIS REMAINING, ONE HUNDRED ONE (101) DUE TO PAIN, SEVENTY-FIVE (75) DUE TO WEAR OF POLYETHYLENE COMPONENT, THIRTY-ONE (31) DUE TO MALALIGNMENT, THIRTY (30) DUE TO ASEPTIC LOOSENING OF THE PATELLA, TWENTY-ONE (21) DUE TO INSTABILITY, EIGHTEEN (18) DUE TO DISLOCATION/SUBLUXATION, FIFTEEN (15) DUE TO ASEPTIC LOOSENING OF THE FEMUR, THIRTEEN (13) DUE TO INFECTION, TEN (10) DUE TO STIFFNESS, EIGHT (8) DUE TO COMPONENT DISSOCIATION, TEN (10) DUE TO PERIPROSTHETIC FRACTURE, SIX (6) DUE TO ASEPTIC LOOSENING OF THE TIBIA, SIX (6) DUE TO IMPLANT FRACTURE, THREE (3) DUE TO LYSIS OF THE TIBIA, ONE (1) DUE TO LYSIS OF THE FEMUR, AND FORTY-NINE (49) DUE TO OTHER REASONS. MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE PROCEDURE. OF THE 548 TOTAL REVISION SURGERIES, 514 WERE PREVIOUSLY SUBMITTED TO FDA AND 34 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 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. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF THREE THOUSAND ONE HUNDRED AND FIFTY-TWO (3,152) KNEES UNDERWENT PRIMARY PATELLOFEMORAL KNEE ARTHROPLASTY IN WHICH A JOURNEY PFJ SYSTEM WAS IMPLANTED IN UNITED KINGDOM BETWEEN 13-OCT-2005 AND 28-APR-2026. BY OBSERVING THE CUMULATIVE REVISION RATES ABOVE, AT THE 3RD AND 10TH POSTOPERATIVE YEARS, THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE REVISION RATES OF THE STUDY DEVICE AND THE CLASS, AS DETERMINED BY OVERLAPPING 95% CONFIDENCE INTERVALS. HOWEVER, THERE IS A STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE REVISION RATES OF THE STUDY DEVICE AND THE CLASS AT THE 1ST AND 5TH POSTOPERATIVE YEARS, AS DETERMINED BY NON-OVERLAPPING 95% CONFIDENCE INTERVALS, WITH THE JOURNEY PFJ SYSTEM DEMONSTRATING HIGHER REVISION RATES THAN THE CLASS. THE MOST COMMON REASON FOR REVISION IS PROGRESSIVE OSTEOARTHRITIS (9.66%), WHICH IS 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 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. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR 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

BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN KNEE ARTHROPLASTY: 1. PRIMARY PATELLOFEMORAL KNEE ARTHROPLASTY JOURNEY PFJ SYSTEM: IMPLANTED IN A TOTAL OF THREE THOUSAND ONE HUNDRED AND FIFTY-TWO (3,152) KNEES BETWEEN 13-OCT-2005 AND 28-APR-2026. THESE INCLUDE TWO THOUSAND NINE HUNDRED AND EIGHTY-TWO (2,982) SYSTEMS WITH A GENESIS II PATELLAR IMPLANT, AND ONE HUNDRED AND SEVENTY (170) SYSTEMS WITH OFF-LABEL PATELLAR IMPLANTS. OF THESE, FIVE HUNDRED AND FORTY-EIGHT (548) KNEES REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE HUNDRED TEN (310) KNEES DUE TO PROGRESSIVE ARTHRITIS REMAINING, ONE HUNDRED ONE (101) DUE TO PAIN, SEVENTY-FIVE (75) DUE TO WEAR OF POLYETHYLENE COMPONENT, THIRTY-ONE (31) DUE TO MALALIGNMENT, THIRTY (30) DUE TO ASEPTIC LOOSENING OF THE PATELLA, TWENTY-ONE (21) DUE TO INSTABILITY, EIGHTEEN (18) DUE TO DISLOCATION/SUBLUXATION, FIFTEEN (15) DUE TO ASEPTIC LOOSENING OF THE FEMUR, THIRTEEN (13) DUE TO INFECTION, TEN (10) DUE TO STIFFNESS, EIGHT (8) DUE TO COMPONENT DISSOCIATION, TEN (10) DUE TO PERIPROSTHETIC FRACTURE, SIX (6) DUE TO ASEPTIC LOOSENING OF THE TIBIA, SIX (6) DUE TO IMPLANT FRACTURE, THREE (3) DUE TO LYSIS OF THE TIBIA, ONE (1) DUE TO LYSIS OF THE FEMUR, AND FORTY-NINE (49) DUE TO OTHER REASONS. MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE PROCEDURE. OF THE 548 TOTAL REVISION SURGERIES, 514 WERE PREVIOUSLY SUBMITTED TO FDA AND 34 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER.