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

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00287007-1-L186,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L187,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L188,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L189,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L190,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L191,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L192,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L193,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L194,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L195,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L196,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L197,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L198,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L199,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L200,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;CASE-2025-00287007-1-L201,,7/7/2026,6/3/2026,JOURNEY PFJ Patellofemoral Joint Knee System,JOURNEY PATELLO FEMORAL IMPLANT,,,,,,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eight hundred and four (804) joints underwent primary patellofemoral joint replacements between 30-Nov-2006 and 27-Feb-2026, 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: 2 (April 1 - June 30, 2026);;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 patella-trochlear knee replacements between 30-Nov-2006 and 27-Feb-2026, using a JOURNEY PFJ Patellofemoral Joint Knee System. From these, two hundred one (201) knees required revision: one hundred eighty-five (185) knees with a GEN II Tibial or Other unspecified Tibial Component required revision 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. Sixteen (16) knees with a Genesis II Tibial Component required revision for the same reasons listed above; however, due to the stratification provided by the Joint Registry, the quantity of knees revised per revision reason cannot be determined.;It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry Data: 30-Nov-2006 to 27-Feb-2026;;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 patella-trochlear knee replacements in Australia between 30-Nov-2006 and 27-Feb-2026. ;These components have been paired and reviewed based on the following subcategories: JOURNEY PFJ component with Resurfacing Patellar component, and JOURNEY PFJ component with Biconvex Patellar component.;The JOURNEY PFJ Patellofemoral Joint Knee System is performing in line with the respective class subcategory at the available follow-up time periods based on overlapping of confidence intervals.;The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. JOURNEY PFJ component with Resurfacing Patellar component:;- At 1st postoperative year: 2.2% (1.2%-4.1%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 5.0% (3.3%-7.5%) vs 4.7% (4.1%-5.3%) of the class.;- At 3rd postoperative year: 7.8% (5.6%-10.8%) vs 7.5% (6.8%-8.2%) of the class.;-At 4th postoperative year: 9.7% (7.2%-13.0%) vs 10.1% (9.3%-11.0%) of the class.;-At 5th postoperative year: 12.4% (9.5%-16.1%) vs 12.2% (11.3%-13.2%) of the class.;-At 6th postoperative year: 15.5% (12.2%-19.7%) vs 14.3% (13.3%-15.3%) of the class.;-At 7th postoperative year: 19.7% (15.9%-24.3%) vs 17.2% (16.1%-18.3%) of the class.;-At 8th postoperative year: 21.6% (17.6%-26.5%) vs 19.5% (18.4%-20.8%) of the class.;-At 9th postoperative year: 23.8% (19.5%-29.0%) vs 22.0% (20.7%-23.3%) of the class.;-At 10th postoperative year: 26.6% (21.8%-32.1%) vs 24.6% (23.2%-26.0%) of the class.;-At 11th postoperative year: 29.5% (24.4%-35.5%) vs 26.7% (25.3%-28.2%) of the class.;-At 12th postoperative year: 32.2% (26.7%-38.5%) vs 29.6% (28.0%-31.2%) of the class.;-At 13th postoperative year: 35.4% (29.4%-42.1%) vs 32.9% (31.2%-34.6%) of the class.;-At 14th postoperative year: 37.3% (31.0%-44.4%) vs 35.2% (33.5%-37.1%) of the class.;;2. JOURNEY PFJ component with Biconvex Patellar component:;-At 1st postoperative year: 2.9% (1.5%-5.5%) vs 1.9% (1.6%-2.3%) of the class.;-At 2nd postoperative year: 6.8% (4.5%-10.2%) vs 4.6% (4.0%-5.2%) of the class.;-At 3rd postoperative year: 9.1% (6.4%-12.9%) vs 7.4% (6.7%-8.1%) of the class.;-At 4th postoperative year: 11.5% (8.4%-15.7%) vs 10.0% (9.2%-10.9%) of the class.;-At 5th postoperative year: 13.7% (10.3%-18.1%) vs 12.1% (11.3%-13.1%) of the class.;-At 6th postoperative year: 14.4% (10.9%-18.9%) vs 14.4% (13.4%-15.4%) of the class.;-At 7th postoperative year: 17.2% (13.3%-22.1%) vs 17.4% (16.3%-18.5%) of the class.;-At 8th postoperative year: 18.5% (14.4%-23.5%) vs 19.8% (18.6%-21.0%) of the class.;-At 9th postoperative year: 20.7% (16.4%-26.0%) vs 22.2% (21.0%-23.5%) of the class.;-At 10th postoperative year: 24.1% (19.3%-29.7%) vs 24.8% (23.4%-26.2%) of the class.;-At 11th postoperative year: 25.7% (20.7%-31.6%) vs 27.0% (25.6%-28.5%) of the class.;-At 12th postoperative year: 31.1% (25.5%-37.6%) vs 29.7% (28.1%-31.3%) of the class.;-At 13th postoperative year: 33.7% (27.8%-40.5%) vs 33.0% (31.3%-34.7%) of the class.;-At 14th postoperative year: 34.4% (28.4%-41.3%) vs 35.5% (33.7%-37.3%) of the class.;-At 15th postoperative year: 39.1% (32.6%-46.5%) vs 38.5% (36.5%-40.5%) of the class.;-At 16th postoperative year: 39.1% (32.6%-46.5%) vs 40.5% (38.5%-42.6%) 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,,0;

Description of Event or Problem

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 KNEE REPLACEMENT PROCEDURES: 1. PRIMARY KNEE PROCEDURES: - JOURNEY PFJ PATELLOFEMORAL JOINT KNEE SYSTEM COMPONENTS: IMPLANTED IN EIGHT HUNDRED AND FOUR (804) JOINTS BETWEEN 30-NOV-2006 AND 27-FEB-2026. FROM THESE, TWO HUNDRED ONE (201) KNEES REQUIRED REVISION: ONE HUNDRED EIGHTY-FIVE (185) KNEES WITH A GEN II TIBIAL OR OTHER UNSPECIFIED TIBIAL COMPONENT REQUIRED REVISION 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. SIXTEEN (16) KNEES WITH A GENESIS II TIBIAL COMPONENT REQUIRED REVISION FOR THE SAME REASONS LISTED ABOVE; HOWEVER, DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE QUANTITY OF KNEES REVISED PER REVISION REASON CANNOT BE DETERMINED. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. OF THE 201 TOTAL REVISION SURGERIES, 185 WERE PREVIOUSLY SUBMITTED TO FDA AND 16 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER.

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2026) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN KNEE REPLACEMENT PROCEDURES: 1. PRIMARY KNEE PROCEDURES: - JOURNEY PFJ PATELLOFEMORAL JOINT KNEE SYSTEM COMPONENTS: IMPLANTED IN EIGHT HUNDRED AND FOUR (804) JOINTS BETWEEN 30-NOV-2006 AND 27-FEB-2026. FROM THESE, TWO HUNDRED ONE (201) KNEES REQUIRED REVISION: ONE HUNDRED EIGHTY-FIVE (185) KNEES WITH A GEN II TIBIAL OR OTHER UNSPECIFIED TIBIAL COMPONENT REQUIRED REVISION 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. SIXTEEN (16) KNEES WITH A GENESIS II TIBIAL COMPONENT REQUIRED REVISION FOR THE SAME REASONS LISTED ABOVE; HOWEVER, DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE QUANTITY OF KNEES REVISED PER REVISION REASON CANNOT BE DETERMINED. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. OF THE 201 TOTAL REVISION SURGERIES, 185 WERE PREVIOUSLY SUBMITTED TO FDA AND 16 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 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 PATELLA-TROCHLEAR KNEE REPLACEMENTS IN AUSTRALIA BETWEEN 30-NOV-2006 AND 27-FEB-2026. THE JOURNEY PFJ PATELLOFEMORAL JOINT KNEE SYSTEM IS PERFORMING IN LINE WITH THE RESPECTIVE CLASS SUBCATEGORY AT THE AVAILABLE FOLLOW-UP TIME PERIODS BASED ON OVERLAPPING OF CONFIDENCE INTERVALS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.