ATTUNE 2545-00-719Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295133919), received between Dec 16, 2020 and May 29, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 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 25336528 ↗
• 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 24449340 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436248 ↗
• 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 23401329 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA), AND THE FEM TRIAL BROKE INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393367 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT POSTERIOR CONDYLES BROKE OFF OF BOTH TRIALS.

  Patient problems: Insufficient Information

  MAUDE report 21998786 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT POSTERIOR CONDYLES BROKE OFF OF BOTH TRIALS.

  Patient problems: Insufficient Information

  MAUDE report 21998785 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT THE LUG HOLE CYLINDER BROKEN. HAS NOT AFFECTED OUTCOME OF SURGICAL TIME. THE DRILL DID NOT GO INTO THE CYLINDER IN THE RIGHT ANGLE, AND SMALL AMOUNT OF THE INSTRUMENT CHIPPED. NO MORE THAN 2 PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815107 ↗
• MalfunctionDec 16, 2020Break; Break

  BROKEN ATTUNE CR FEMORAL TRIAL SIZE 9 LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019707 ↗