ATTUNE 2545-00-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295133827), received between Sep 23, 2019 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 25336289 ↗
• 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 24449350 ↗
• MalfunctionOct 28, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, MEDICAL DEVICE REPROCESSING STATED THAT THEY CANNOT RE-STERILIZE THE ATTUNE SHIMS, FEMORAL TRIALS AND IMPACTORS IN THE SETS DUE TO THEM HAVING MULTIPLE CHIPS AND MICRO CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401328 ↗
• MalfunctionNov 4, 2019Break; Break

  IT WAS REPORTED THAT THE FEMORAL TRIAL WAS BROKEN WHEN IMPACTING ONTO THE FEMUR. ALL PIECES WERE RECOVERED AND THE CASE WAS DELAYED UNTIL THE BACKUP PAN WAS OPENED ABOUT 4 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9274521 ↗
• MalfunctionOct 28, 2019Break; Break

  MDR STAFF REPORTED THAT THE FOLLOWING ATTUNE FEMORAL TRIALS ARE CHIPPED AND REQUIRE REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246565 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING EXTENSION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105347 ↗