ATTUNE 1518-20-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295541561), received between Jun 19, 2023 and Sep 22, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50860423 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSTABILITY, REMOVED A LATERAL SYNTHES PLATE WHICH HAD A SCREW IMPINGING ON POLY. NO ALLEGATION ON THE PLATE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25446614 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE AS BEING TOO LOOSE, REQUIRING THE PHYSICIAN TO MAKE IT TIGHTER. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24958647 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE FEM POR CR LT SZ 4, ATTUNE FB TIB BASE SZ 5 POR, AND ATUNE CR LT MS INS SZ 4 5 WERE INVOLVED IN A REPORTED EVENT. FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION, WHICH NECESSITATED IRRIGATION AND DEBRIDEMENT. SUBSEQUENTLY, A REMOVAL SURGERY WAS PERFORMED, AND ALL IMPLANT COMPONENTS WERE EXTRACTED DUE TO UNCONTROLLABLE INFECTION. CEMENT MOLDING WAS COMPLETED SUCCESSFULLY DURING THE REVISION PROCEDURE. THIS PC IS RELATED TO (B)(4), WHICH REPORTS ON THE POSTOPERATIVE INFECTION AND THE DEBRIDEMENT. THIS PC REPORTS ON THE REMOVAL SURGERY AFTER THE DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 24815049 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  SURGEON REMOVED POLY TO PERFORM A WASH OUT OF THE TOTAL KNEE. SURGEON REPLACED POLY WITH SAME SIZE NEW POLY AS WAS REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24445668 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT PRIMARY SURGERY VIA TKA FOR OA WITH THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SUSPECTED INFECTION OCCURRED ON (B)(6) 2026 AND WAS REPORTED ON (B)(6) 2026. IRRIGATION AND DEBRIDEMENT WERE PERFORMED ON THE SAME DAY. THE PRODUCT WAS REMOVED AND IRRIGATED THOROUGHLY. THERE WAS NO LOOSENESS IN THE OTHER COMPONENTS, SO A NEW PRODUCT OF THE SAME MODEL WAS RE-IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THIS EVENT IS CONSIDERED NOT RELATED TO THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24444178 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF KNEE. LOOSENING INTERFACE WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24291405 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A STIFF KNEE. THE TIBIA RESECTED FOR MORE TIBIAL BONE. DOI: (B)(6) 2025, DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 23795272 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE LINER WAS EXCHANGED TO RULE OUT INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23742136 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TRIPPED AND STRETCHED HER LIGAMENT ENVELOP. PATIENT HAD LAXITY TO LIGAMENTS. THE SURGEON DECIDED TO DEBRIDE KNEE AND INCREASE POLY THICKNESS. NO ISSUES WITH IMPLANTS, NO SUGGESTIONS OF IMPLANT CONCERNS, NO COMPONENT LOOSENING REPORTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23096658 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22376066 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22375954 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21592406 ↗
• MalfunctionMar 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A TKA WITH THE INSERT IN QUESTION FOR KNEE OA. WHEN THE SURGEON OPENED THE STERILIZED PACKAGE, HAIR WAS SEALED IN THE PACKAGE. THE SALES REP STOPPED THE PROCEDURE ONCE AND DISCUSSED WITH THE SALES REP WHETHER TO USE IT OR NOT. THE SURGEON GUESSED THAT THE INSIDE OF THE ALUMINUM WOULD NOT BE DIRTY, AND THERE WAS ONLY ONE OF THIS SIZE AVAILABLE. THE SURGEON DECIDED TO USE IT FOR THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21573518 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 20708204 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TIGHT KNEE. SURGEON PERFORMED POLY EXCHANGE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 20242309 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANATION OF LEFT TOTAL KNEE ARTHROPLASTY WITH PLACEMENT OF TEMPORARY ANTIBIOTIC-LOADED SPACER TO ADDRESS RECURRENT CHRONIC INFECTION. DEPUY PRODUCTS WERE PLACED DURING THIS PROCEDURE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2021 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17151333 ↗