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NA 1294-56-116Recalls & reported problems

Depuy (Ireland) · M.B.T. REVISION STEP WEDGE SIZE 1.5 10mm CEMENTED · Class 3 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295026631), received between Jun 13, 2022 and Jun 13, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT EXPERIENCED A BROKEN TIBIA AND NEEDED TO BE REVISED. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Bone Fracture(s)

    MAUDE report 14676869 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices

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Sources and updates

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