ATTUNE 1514-04-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295520641), received between Jul 25, 2024 and Dec 31, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 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 FOR INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 23934866 ↗
• InjuryMar 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21549380 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN ATTUNE REV KNEE CONSTRUCT WAS IN. IT WAS REVISED WITH A SINGLE STAGE REIMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20145308 ↗
• MalfunctionJul 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE ITEMS WERE DAMAGED IN TRANSIT. THE OUTER BOXES WERE SMASHED IN TRANSIT AND CAUSED THE IMPLANTS TO BE DAMAGED AS WELL. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825675 ↗