ATTUNE 1516-20-814Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295046066), received between Oct 31, 2023 and Jul 1, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A WASHOUT AND POLY EXCHANGE. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22375917 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS PERFORMED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18094543 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIAL INSERT WAS REMOVED DUE TO INFECTION. WASH OUT PERFORMED. DOI: (B)(6), 2016. DOR: (B)(6), 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18039858 ↗