ATTUNE 2545-05-403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295481461), received between Jul 9, 2020 and Dec 28, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT DURING TRIAL NG THE PS ATTUNE 8 BY 5 MM THICK INSERT CRACKED IN HALF. BOTH PIECES WERE RETRIEVED FROM THE PATIENT AND WE USED THE MODULAR TRIAL INSERTS. VERY LITTLE TIME WAS ADDED TO THE CASE. 2 MINUTES MAX.

  Patient problems: Insufficient Information

  MAUDE report 13093035 ↗
• MalfunctionJan 13, 2021Crack; Crack

  IT WAS REPORTED THAT POLY WAS CRACKED WHEN THE SURGEON ATTEMPTED TO INSERT. THE SURGERY WAS NOT DELAYED AND NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166357 ↗
• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT THE BACK SIDE OF THE POLY HAS SOME CHIPS. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251857 ↗