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

Report

• Report Number: 1020279-2025-01730
• Event Type: Injury
• Date Received: October 20, 2025
• Report Date: October 28, 2025
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: KRR
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 3 (01-JUL-2025 TO 30-SEP-2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY PATELLOFEMORAL JOINT REPLACEMENT PROCEDURES: 1. PRIMARY PATELLOFEMORAL JOINT REPLACEMENT PROCEDURES: JOURNEY PATELLOFEMORAL JOINT (PFJ) KNEE REPLACEMENT: IMPLANTED IN EIGHT HUNDRED AND FOUR (804) JOINTS BETWEEN 30-NOV-2006 AND 25-MAR-2025. FROM THESE, ONE HUNDRED AND EIGHTY-FIVE (185) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED AND NINETEEN (119) KNEES DUE TO PROGRESSION OF DISEASE, EIGHTEEN (18) KNEES DUE TO LOOSENING, SEVENTEEN (17) KNEES DUE TO PAIN, ONE (1) KNEE DUE TO IMPLANT BREAKAGE ¿ PATELLA, FOUR (4) KNEES DUE TO WEAR ¿ PATELLA, FOUR (4) KNEES DUE TO INFECTION, FOUR (4) KNEES DUE TO MALALIGNMENT, THREE (3) KNEES DUE TO INSTABILITY, FOUR (4) KNEES DUE TO LYSIS, ONE (1) KNEE DUE TO FRACTURE, FOUR (4) KNEES DUE TO PATELLA MALTRACKING, ONE (1) KNEE DUE TO WEAR OF TIBIAL INSERT, ONE (1) KNEE DUE TO PROSTHESIS DISLOCATION, ONE (1) KNEE DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO INCORRECT SIZING, ONE (1) KNEE DUE TO IMPLANT BREAKAGE ¿ FEMORAL, AND ONE (1) KNEE DUE TO OTHER-UNKNOWN REASON. BASED ON THE STRATIFICATION USED BY THE AOANJRR, THESE REASONS FOR REVISION CANNOT BE DEFINITIVELY LINKED TO THE INDIVIDUAL JOURNEY PATELLOFEMORAL JOINT (PFJ) KNEE COMPONENTS REFERENCED IN THE .CSV FILE AND REPORTED AS INVOLVED IN REVISION SURGERIES. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE JOURNEY PFJ PATELLOFEMORAL JOINT KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR REPORTS THAT FOR THE JOURNEY PFJ PATELLOFEMORAL JOINT KNEE SYSTEM, THE CUMULATIVE REVISION RATES (25.20%) WERE IN LINE WITH THE CLASS DEVICE (25.00%) AT 10 YEARS OF FOLLOW-UP, BASED ON THE OVERLAPPING CONFIDENCE INTERVALS. PROGRESSION OF DISEASE WAS THE MOST COMMON REASON FOR REVISION OF JOURNEY PFJ IMPLANTS (18.8%) AND THE CLASS DEVICE (13.3%). PROGRESSION OF DISEASE AFTER PFJ IS A COMMON OCCURRENCE AFTER PFJ PROCEDURES AND NOT SPECIFICALLY RELATED TO IMPLANT PERFORMANCE. SPECIFIC ANALYSIS IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Additional Manufacturer Narrative · 0

H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT, PREVIOUSLY SUBMITTED ON 20-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN THE ATTACHED CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE-ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: (B)(4). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00287007-1-L1,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L2,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L3,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L4,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L5,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L6,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L7,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L8,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L9,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L10,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L11,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L12,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L13,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L14,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L15,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL LEFT,71461010,,71461010,,03596010573308,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L16,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L17,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L18,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L19,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L20,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L21,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L22,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L23,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L24,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L25,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L26,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L27,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L28,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL IMPLANT X-SMALL RIGHT,71461011,,71461011,,03596010573315,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L29,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L30,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L31,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L32,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L33,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L34,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L35,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L36,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L37,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L38,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L39,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L40,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L41,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L42,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L43,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L44,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L45,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L46,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L47,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L48,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L49,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L50,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L51,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L52,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L53,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L54,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L55,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L56,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L57,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L58,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L59,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L60,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L61,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLOFEMORAL JOINT IMPLANT SMALL LEFT,71461012,,71461012,,03596010544193,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L62,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L63,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L64,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L65,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L66,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L67,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L68,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L69,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L70,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L71,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L72,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L73,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L74,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L75,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L76,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L77,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L78,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L79,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L80,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L81,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L82,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L83,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L84,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L85,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L86,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L87,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L88,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L89,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L90,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L91,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L92,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L93,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L94,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L95,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L96,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L97,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L98,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L99,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L100,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L101,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L102,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L103,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L104,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L105,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L106,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L107,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L108,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL JOINT IMPLANT SM RT,71461013,,71461013,,03596010544209,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L109,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L110,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L111,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L112,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L113,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L114,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L115,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L116,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L117,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L118,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L119,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L120,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L121,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L122,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L123,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L124,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L125,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L126,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L127,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L128,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L129,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L130,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L131,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L132,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L133,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L134,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L135,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEYPATELLO FEMORAL IMPLANT MED LT,71461014,,71461014,,03596010544216,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L136,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L137,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L138,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L139,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L140,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L141,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L142,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L143,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L144,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L145,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L146,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L147,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L148,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L149,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L150,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L151,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L152,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L153,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L154,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L155,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L156,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L157,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L158,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L159,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L160,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L161,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT MED RT,71461015,,71461015,,03596010544223,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L162,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L163,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L164,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L165,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L166,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L167,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L168,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L169,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L170,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG LT,71461016,,71461016,,03596010544230,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L171,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L172,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L173,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L174,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L175,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L176,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L177,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L178,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L179,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L180,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L181,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L182,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L183,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L184,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00287007-1-L185,,10/20/2025,7/1/2025,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT LG RT,71461017,,71461017,,03596010544247,K051086,,,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one (1) patient required revision surgery due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual Patellofemoral Joint Knee component reported through this line item.","Reporting Quarter: 3 (01-Jul-2025 to 30-Sep-2025);;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 25-Mar-2025, upon which a JOURNEY PFJ Patellofemoral Joint Knee System was placed. From these, one hundred and eighty-five (185) knees were later revised due to the following reasons: one hundred and nineteen (119) knees due to progression of disease, eighteen (18) knees due to loosening, seventeen (17) knees due to pain, one (1) knee due to implant breakage ¿ patella, four (4) knees due to wear ¿ patella, four (4) knees due to infection, four (4) knees due to malalignment, three (3) knees due to instability, four (4) knees due to lysis, one (1) knee due to fracture, four (4) knees due to patella maltracking, one (1) knee due to wear of tibial insert, one (1) knee due to prosthesis dislocation, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, one (1) knee due to implant breakage ¿ femoral, and one (1) knee due to other-unknown reason. Based on the stratification used by the AOANJRR, these reasons for revision cannot be definitively linked to the individual JOURNEY Patellofemoral Joint (PFJ) Knee Components referenced in the .csv file and reported as involved in revision surgeries. ;;Timeframe of Registry Data: 30-Nov-2006 to 25-Mar-2025;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY PFJ Patellofemoral Joint Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements in Australia between 30-Nov-2006 and 25-Mar-2025. During the first 16 years, the JOURNEY PFJ Patellofemoral Joint Knee System performs comparably to other patellofemoral joint knee systems based on overlapping 95% confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿At 1st postoperative year: 2.3% (1.4%¿3.6%) vs 1.9% (1.5%¿2.3%) of the class.;¿At 2nd postoperative year: 5.5% (4.1%¿7.4%) vs 4.6% (4.0%¿5.2%) of the class.;¿At 3rd postoperative year: 8.1% (6.4%¿10.3%) vs 7.4% (6.7%¿8.2%) of the class.;¿At 4th postoperative year: 10.1% (8.1%¿12.6%) vs 10.1% (9.3%¿11.0%) of the class.;¿At 5th postoperative year: 12.6% (10.3%¿15.3%) vs 12.3% (11.4%¿13.3%) of the class.;¿At 6th postoperative year: 14.9% (12.4%¿17.9%) vs 14.5% (13.4%¿15.6%) of the class.;¿At 7th postoperative year: 17.6% (14.8%¿20.8%) vs 17.4% (16.3%¿18.6%) of the class.;¿At 8th postoperative year: 19.3% (16.4%¿22.7%) vs 19.8% (18.6%¿21.1%) of the class.;¿At 9th postoperative year: 21.7% (18.6%¿25.4%) vs 22.3% (21.0%¿23.7%) of the class.;¿At 10th postoperative year: 25.2% (21.7%¿29.2%) vs 24.9% (23.4%¿26.4%) of the class.;¿At 11th postoperative year: 27.6% (23.9%¿31.8%) vs 27.1% (25.6%¿28.7%) of the class.;¿At 12th postoperative year: 31.0% (26.9%¿35.5%) vs 29.9% (28.3%¿31.7%) of the class.;¿At 13th postoperative year: 34.2% (29.8%¿39.0%) vs 33.2% (31.4%¿35.1%) of the class.;¿At 14th postoperative year: 35.1% (30.6%¿40.1%) vs 35.8% (33.9%¿37.8%) of the class.;¿At 15th postoperative year: 40.7% (35.4%¿46.6%) vs 38.4% (36.4%¿40.6%) of the class.;¿At 16th postoperative year: 41.6% (36.1%¿47.5%) vs 40.7% (38.5%¿43.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY PATELLOFEMORAL JOINT REPLACEMENT PROCEDURES: 1. PRIMARY PATELLOFEMORAL JOINT REPLACEMENT PROCEDURES: JOURNEY PATELLOFEMORAL JOINT (PFJ) KNEE REPLACEMENT: IMPLANTED IN EIGHT HUNDRED AND FOUR (804) JOINTS BETWEEN 30-NOV-2006 AND 25-MAR-2025. FROM THESE, ONE HUNDRED AND EIGHTY-FIVE (185) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED AND NINETEEN (119) KNEES DUE TO PROGRESSION OF DISEASE, EIGHTEEN (18) KNEES DUE TO LOOSENING, SEVENTEEN (17) KNEES DUE TO PAIN, ONE (1) KNEE DUE TO IMPLANT BREAKAGE ¿ PATELLA, FOUR (4) KNEES DUE TO WEAR ¿ PATELLA, FOUR (4) KNEES DUE TO INFECTION, FOUR (4) KNEES DUE TO MALALIGNMENT, THREE (3) KNEES DUE TO INSTABILITY, FOUR (4) KNEES DUE TO LYSIS, ONE (1) KNEE DUE TO FRACTURE, FOUR (4) KNEES DUE TO PATELLA MALTRACKING, ONE (1) KNEE DUE TO WEAR OF TIBIAL INSERT, ONE (1) KNEE DUE TO PROSTHESIS DISLOCATION, ONE (1) KNEE DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO INCORRECT SIZING, ONE (1) KNEE DUE TO IMPLANT BREAKAGE ¿ FEMORAL, AND ONE (1) KNEE DUE TO OTHER-UNKNOWN REASON. BASED ON THE STRATIFICATION USED BY THE AOANJRR, THESE REASONS FOR REVISION CANNOT BE DEFINITIVELY LINKED TO THE INDIVIDUAL JOURNEY PATELLOFEMORAL JOINT (PFJ) KNEE COMPONENTS REFERENCED IN THE .CSV FILE AND REPORTED AS INVOLVED IN REVISION SURGERIES. ALTOGETHER, A TOTAL QUANTITY OF ONE HUNDRED AND EIGHTY-FIVE (185) REVISIONS HAVE BEEN REPORTED IN THE AOANJRR FOR THE JOURNEY PATELLOFEMORAL JOINT (PFJ) REPLACEMENT COMPONENTS SUMMARIZED THROUGH THIS 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2230214		PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	KRR	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR	Unknown

Terms

Patient problem · 10

• Aseptic loosening
• Deformity/ Disfigurement
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Necrosis
• Osteolysis
• Pain
• Periprosthetic fracture
• Unspecified Infection

Product problems · 6

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Improper or Incorrect Procedure or Method
• Malposition of Device
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission