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OXFORD UNICOMPARTMENTAL KNEE PHASE 3SPHERICAL CUTTER 32-420329Recalls & reported problems

Biomet Uk Ltd · 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 05019279482252), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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

Device problems

  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 15, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT THE DOCTOR HAS REPORTED THAT THE REAMER (SPHERICAL CUTTER) IS NOT PERFORMING AS REQUIRED, AND HAS REQUESTED A REPLACEMENT. EXCESS FORCE HAD TO BE APPLIED FOR THE REAMER TO CUT. NO DELAY REPORTED. NO HARM OF THE PATIENT OR THE USER REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11482923 ↗

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Sources and updates

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