ATTUNE 1518-20-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295541660), received between Jul 16, 2024 and Jul 17, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS EXCHANGED DUE TO AN INFECTION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25861624 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON PERFORMED I&D FOR DRAINAGE. INSERT WAS EXPLANTED AND REPLACED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24942310 ↗
• MalfunctionDec 5, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULD NOT SEAT IN THE TIBIAL TRAY. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729171 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISIONS DUE TO INSTABILITY AND PAIN. SURGEON DECIDED TO RESURFACE AN UN RESURFACED PATELLA. MAYBE DUE TO UNRESURFACED PATELLA, ALSO DECIDED TO INCREASE CONSTRAINT LEVEL TO HELP WITH STABILITY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23008771 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP FOR INFECTED KNEE. NO ALLEGATIONS MADE AGAINST ANY PRODUCTS. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22346561 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO SUSPECTED INFECTION. DURING THE CASE, THE SURGEON DECIDED TO SWAP OUT THE TIBIAL INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22309106 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20928910 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. 2. WHAT WAS THE REASON FOR REVISION? - IT BAND PAIN. 3. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS NO.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19753641 ↗