ATTUNE 2546-00-488Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295490418), received between Sep 24, 2021 and Sep 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT THE SIZE 6 PS RP ARTICULATING SURFACE AND 6MM SHIM CRACKED WHILE REMOVING FROM TRIALING COMPONENTS. THEY DID NOT BREAK INTO PIECES, BUT WERE VISIBLY CRACKED. THE SIZE 4 FEMORAL SHIM AND SIZE 8 FEMORAL SHIM WERE NOT USED IN THE CASE BUT UPON EXAMINING AFTER THE CASE, SMALL SURFACE CHIPS WERE NOTICED THAT COULD CAUSE SCRATCHING OF THE IMPLANTS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526941 ↗