ATTUNE 2544-91-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295443810), received between Jul 21, 2021 and Jul 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ONE OF THE SURGEONS SAID THAT WE NEED TO DO SOMETHING ABOUT OUR ATTUNE ALL POLY IMPACTORS. HE STATED THAT THERE NEEDS TO BE A COLOR CHANGE AS THE WHITE COLOR OF THE IMPACTOR WAS TOO CLOSE IN COLOR TO THE BONE CEMENT AND THAT THE TINY CEMENT FLECKS ARE BEING MISSED IN STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247820 ↗
• MalfunctionJul 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE CEMENT FRAGMENTS REMAIN ON WHILE IMPACTING AND CANNOT BE SEEN. IT WAS ALSO REPORTED A DIFFERENT COLOR IS NEEDED TO SEE RESIDUAL CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204823 ↗