ATTUNE 1518-20-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295541769), received between Jan 9, 2024 and Jul 27, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Poly exchange was performed due to infection.DOI: Unknown.DOR: (b)(6)2026.Affected side: Left knee.

  Patient problems: Unspecified Infection

  MAUDE report 50036571 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A GLOBALLY LOOSE TOTAL KNEE ARTHROPLASTY (TKA). DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23929998 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLYETHYLENE INSERT WAS EXPLANTED DUE TO INFECTION. THERE WERE NO DELAYS IN CASE, PATIENT WAS NOT HARMED. INSERT WAS REMOVED FROM THE FIELD AND DISPOSED OF. ENTIRE INSERT WAS ACCOUNTED FOR. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22213918 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWED SIGNS OF INFECTION AND LACK OF EXTENSION MECHANISMS. SURGEON EXCHANGED A 7MM POLY FOR A 10MM AND ACHIEVED THE GOALS. THERE WAS NO HARM TO THE PATIENT OR DELAY TO THE CASE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Unspecified Infection

  MAUDE report 21139093 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BIGGER SIZE INSERT WAS NEEDED.

  Patient problems: Joint Laxity

  MAUDE report 18676934 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A WASHOUT DUE TO INFECTION. NEW POLY IMPLANTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18475131 ↗