ATTUNE 1516-20-612Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295045816), received between May 18, 2021 and Apr 21, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LEFT INFECTED KNEE. SURGEON PER FORMED INCISION AND DRAINAGE WITH POLYETHYLENE EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 24936399 ↗
• MalfunctionMay 3, 2022Expiration Date Error; Expiration Date Error

  THE IMPLANT WAS EXPIRED AND WAS IMPLANTED INTO PATIENT. DATE OF IMPLANTATION WAS (B)(6) 2022 AND DATE OF EXPIRATION WAS (B)(6) 2022. NO ADVERSE AFFECTS ON PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270448 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND COMPLETELY HAD HIS INCISION OPENED. HAD EVULSED LATERAL EPICONDYLE WHICH WAS REATTACHED WITH A SCREW. INCREASED POLY THICKNESS BY 2MM. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 11841324 ↗