ATTUNE 2545-00-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295133810), received between Jun 23, 2017 and May 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 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 25336118 ↗
• 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 24449316 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436243 ↗
• 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 23401320 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT PLASTIC TRIAL BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369716 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT THE POSTERIOR CONDYLE BROKE OFF WHEN THE TRIAL WAS IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720786 ↗
• MalfunctionJun 22, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE POSTERIOR CONDYLE WAS BROKEN OFF. ALL PIECES RECOVERED. SURGERY WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040502 ↗
• 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 9246567 ↗
• MalfunctionApr 11, 2019Break; Break

  IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE WHEN INSERTING FOR TRAILING.

  Patient problems: No Code Available

  MAUDE report 8504678 ↗
• MalfunctionJun 23, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD TOTAL KNEE REPLACEMENT. THERE IS DAMAGE TO THE PLASTIC TRIAL FEMUR. DAMAGE TO UPPER OUTER SURFACE ACCORDING TO HOSPITAL. LIKELY FROM SAW BLADE WHEN CUTTING THE PATELLA.

  Patient problems: No Information

  MAUDE report 6664918 ↗