Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-08-11Open, ClassifiedProcess change control

  Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

  The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

• 2026-08-05Open, ClassifiedProcess design

  Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

  Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

• 2026-06-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012. 3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D; Part Number: 151730014. 4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E; Part Number: 151730016. 5. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN F; Part Number: 151730018. 6. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN G; Part Number: 151730020. 7. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN H; Part Number: 151730022. 8. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN I; Part Number: 151730024. 9. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN J; Part Number: 151730026. 10. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN K; Part Number: 151730028. 11. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN L; Part Number: 151730030. 12. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN M; Part Number: 151730032. 13. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN N; Part Number: 151730034. 14. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN P; Part Number: 151730038. 15. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN Q; Part Number: 151730040. 16. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN R; Part Number: 151730042. 17. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN S; Part Number: 151730044. 18. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN T; Part Number: 151730046. 19. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN U; Part Number: 151730048. 20. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN V; Part Number: 151730050. 21. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN W; Part Number: 151730052. 22. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN X; Part Number: 151730036.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-06-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B; Part Number: 151730416. 5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm B; Part Number: 151730418. 6. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 20mm B; Part Number: 151730420. 7. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 22mm B; Part Number: 151730422. 8. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 24mm B; Part Number: 151730424. 9. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 26mm B; Part Number: 151730426. 10. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 8mm B; Part Number: 151730408. 11. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 10mm C; Part Number: 151730510. 12. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 12mm C; Part Number: 151730512. 13. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 14mm C; Part Number: 151730514. 14. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 16mm C; Part Number: 151730516. 15. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 18mm C; Part Number: 151730518. 16. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 20mm C; Part Number: 151730520. 17. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 22mm C; Part Number: 151730522. 18. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 24mm C; Part Number: 151730524. 19. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 26mm C; Part Number: 151730526. 20. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 8mm C; Part Number: 151730508. 21. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 10mm E; Part Number: 151730710. 22. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 12mm E; Part Number: 151730712. 23. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 14mm E; Part Number: 151730714. 24. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 16mm E; Part Number: 151730716. 25. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 18mm E; Part Number: 151730718. 26. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 20mm E; Part Number: 151730720. 27. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 22mm E; Part Number: 151730722. 28. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 24mm E; Part Number: 151730724. 29. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 26mm E; Part Number: 151730726. 30. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 8mm E; Part Number: 151730708. 31. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 10mm W; Part Number: 151730810. 32. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 12mm W; Part Number: 151730812. 33. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 14mm W; Part Number: 151730814. 34. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 16mm W; Part Number: 151730816. 35. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 18mm W; Part Number: 151730818. 36. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 20mm W; Part Number: 151730820. 37. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 22mm W; Part Number: 151730822. 38. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 8mm F; Part Number: 151730808. 39. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 24mm W; Part Number: 151730824. 40. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 26mm W; Part Number: 151730826.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.