ATTUNE 1516-20-907Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295046141), received between Nov 18, 2019 and May 8, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Naturally Worn; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL COMPONENT AND POLYETHYLENE WEAR. AT REMOVAL THERE WAS NO CEMENT REMAINING ON THE TIBIAL COMPONENT. UNKNOWN CEMENT MFG. IT IS UNKNOWN IF THE PATELLA WAS RESURFACED.

  Patient problems: Insufficient Information

  MAUDE report 21986429 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SOME INSTABILITY ISSUES AND THE SURGEON ORIGINALLY INTENDED TO COMPLETE A FULL REVISION, BUT ASKED LAST MINUTE TO HAVE MEDIAL STABILIZED IMPLANTS AVAILABLE FOR A POLY EXCHANGE. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17833548 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKR 4/6. REASON FOR REVISION WAS DUE TO WOUND BREAKDOWN. WOUND WASHOUT AND PROPHYLACTIC POLY CHANGE. INFECTION WAS NOT CONFIRMED. AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 12158325 ↗
• MalfunctionJun 14, 2021Difficult to Insert; Difficult to Insert

  POLY INSERT WOULD NOT SEAT. TRIED REMOVING AND RESEATING MULTIPLE TIMES. DOWNSIZED POLY AND INSERTED. SURGEON HAPPY WITH SEATING. SURGEON NEW TO SYSTEM. SURGERY DELAYED 20 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995443 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE DUE TO STIFFNESS, ADHESIONS, AND DECREASED RANGE OF MOTION. DOI: (B)(6) 2017. DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9337555 ↗