ATTUNE 1516-20-614Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295045823), received between Oct 4, 2019 and Jul 21, 2020 — 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 16, 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 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. POLYETHYLENE EXCHANGE WAS DONE. DOI: (B)(6) 2017; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10304984 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND STREP-A INFECTION. THE POLY WAS REMOVED AND THE KNEE WAS THOROUGHLY IRRIGATED AND REPLACED WITH A NEW POLY. PATIENT WAS PUT ON ANTIBIOTICS. FULL RANGE OF MOTION WAS STILL INTACT AFTER CLOSURE. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10039526 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FLEXION INSTABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9158758 ↗