ATTUNE 2545-00-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295133926), received between Feb 26, 2018 and May 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Break; Crack

  IT WAS REPORTED THE STERILE PROCESSING DEPARTMENT CANNOT RE-STERILIZE THE ATTUNE SHIMS, FEMORAL TRIALS AND IMPACTORS IN THE SETS DUE TO THEM HAVING MULTIPLE CHIPS AND MICRO CRACKS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336730 ↗
• MalfunctionFeb 25, 2026Break; Scratched Material

  IT WAS REPORTED THAT THE PLASTIC FEMORAL TRIAL DEVICE WAS SCRATCHED OR CHIPPED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449354 ↗
• MalfunctionOct 27, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THE ATTUNE FEMORAL TRIAL AND SHIM HAD MULTIPLE CHIPS AND MICRO CRACKS, SO THEY COULD NOT BE STERILIZED ANYMORE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390434 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT THE LEFT SIZE 10 CR TRIAL BROKE WHILE TRIALING. ALL PIECES WERE RETRIEVED, THERE WAS NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301891 ↗
• MalfunctionJan 23, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: A. WERE ALL PIECES RETRIEVED FROM THE PATIENT? NO PIECE ENTERED THE PATIENT'S BODY B. WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562757 ↗
• MalfunctionFeb 26, 2018Break; Break

  IT WAS REPORTED THAT FEMORAL TRIAL BROKE, PROBABLY DUE TO THE TRIAL FEMUR NOT BEING SEATED BEFORE THE REDUCTION WAS ATTEMPTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295670 ↗