NA 2294-36-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295113553), received between Apr 16, 2018 and May 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 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.

• MalfunctionMay 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE CASE, A FEW OF THE TRIALS USED DID NOT EFFECTIVELY HOLD ONTO THE STEM TRIALS. THIS DID NOT CREATE ANY MAJOR DELAYS HOWEVER TWICE THE STEM TRIAL CAME LOOSE AND HAD TO BE RETRIEVED FROM THE PATIENT'S TIBIA. FOLLOWING THE CASE, I TESTED THESE TRIALS AND BROACHES AND WILL BE RETURNING THEM TO GET NEW ONES. THE RUBBER GASKET ARE GETTING WORN OUT. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7479127 ↗
• MalfunctionApr 16, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE MBT REVISION TRIAL SIZE 2/2.5/3/4/5 INNER STEM BUSHING IS WORN OUT AND WILL NO LONGER KEEP STEM TRIAL IN ATTACHMENT. NEEDS REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432401 ↗