ATTUNE 1516-31-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295048343), received between Feb 28, 2020 and Jun 24, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. NEEDED TO GO UP ON POLY SIZE. DOI: (B)(6) 2020. DOR: (B)(6) 2021. UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12063940 ↗
• InjuryNov 18, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PRIMARY IMPLANTS WERE OVERSIZED CAUSING PAIN AND SUSPECTED POTENTIAL OSTEOMYELITIS. SURGEON DECIDED TO TAKE ALL IMPLANTS OUT AND REPLACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10860608 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR FLEXION INSTABILITY PCL RUPTURE, ALL COMPONENTS REVISED EXCEPT THE PATELLA.

  Patient problems: No Code Available

  MAUDE report 9771890 ↗