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NA 2294-36-115Recalls & reported problems

Depuy (Ireland) · M.B.T. REVISION TRAY TRIAL SIZE 1.5 · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295113515), received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Code Available1
  • Not Applicable1

Recent adverse event reports

The 1 most recent of 1 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 7479302 ↗

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Sources and updates

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