ATTUNE 1516-21-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295046240), received between Dec 12, 2017 and Apr 30, 2024 — classified as 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED: THERE WAS NO PATIENT HARM, NOR SURGICAL DELAY.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 19213437 ↗
• MalfunctionApr 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT LOCKING MECHANISM DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715856 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 17.7 MONTHS. REASON FOR REVISION: INSTABILITY/PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16370837 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ACUTE INFECTION. POLY EXCHANGE 9 YEARS OUT. LOOSENING AND SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15112537 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT OF LEFT TOTAL KNEE REVISION: THERE WAS INFECTION, REQUIRING FIRST STAGE REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9903395 ↗
• InjuryDec 12, 2017Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS RAPID INCREASE IN PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS FROM DEPUY. IT WAS ALSO REPORTED THAT X-RAYS SHOWS A LARGE ANTERIOR MEDIAL DEFECT ALL THE WAY THROUGH THE BONE. AP X-RAY SHOWS MEDIAL COLLAPSE OF TIBIA. SURGEON FELT THIS WAS A CASE OF ASEPTIC LOOSENING OF TIBIA WITH ADDITIONAL FACTORS OF OBESITY AND POSSIBLE FUNGAL INFECTION. THE LATER WASN¿T CONFIRMED BY PATHOLOGY AT THIS TIME. THE SURGEON WAS CONCERNED WITH THE AMOUNT OF SCRATCHING, PITTING AND WEAR THAT THEY POLY COMPONENTS

  Patient problems: Pain

  MAUDE report 7107636 ↗