ATTUNE 1518-20-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295541899), received between Apr 25, 2024 and Aug 12, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection.DOI: (b)(6) 2024.DOR: (b)(6)2026.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50224677 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ACTIVE INFECTION IN THE KNEE JOINT. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED. THE BONE HAD BEEN EATEN AWAY BY BACTERIA UNDERNEATH THE IMPLANT. DOI-(B)(6) 2025. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24958774 ↗
• MalfunctionMar 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE INSERT DID NOT PROPERLY SEAT ON TRAY AFTER IMPACTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532428 ↗
• MalfunctionJan 14, 2026Difficult to Insert

  IT WAS REPORTED THAT THE INSERT COULD NOT BE SEATED INTO THE TIBIA. TRIED MULTIPLES TIMES. THE INSERT LOOKS FINE. REPORTER OPENED ANOTHER INSERT AND IT WENT IN FIST TRY. DOE: DECEMBER (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072264 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE. NO LOOSENING OR IMPLANT ISSUES. CASE WAS NOT PROLONGED. REPLACED LINER, I&D. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24057869 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCING SOME INSTABILITY AND MILD PAIN DUE TO LAXITY THAT HAS DEVELOPED POST TKA. PATIENT BROUGHT TO OR AND A POLY EXCHANGE WAS PERFORMED TO A THICKER INSERT WHICH WAS SHOWED INCREASED STABILITY WHILE MAINTAINING GOOD ROM. NO PATIENT HARM NOR DELAY OCCURRED. IMPLANTS ARE WELL ALIGNED, WELL FIXED AND APPROPRIATE SIZED WITH NO WEAR NOTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22518939 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INSERT EXCHANGE I&D FOR INFECTION. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22338169 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK FOR A REVISION DUE TO LIMITED RANGE OF MOTION FROM HIS TOTAL KNEE. ALL COMPONENTS, BESIDES PATELLA WERE REMOVED AND A CRS RP REVISION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22031720 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAW REVISED DUE TO INFECTION. REMOVAL OF IMPLANTS AND IMPLANTATION OF SPACER WAS DONE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19180571 ↗