Oxford® Uni Knee System 32-423232Recalls & reported problems
Biomet Uk Ltd · Class 1
All models of Oxford Uni Knee System (22)
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 05019279447992), received between Sep 30, 2021 and Sep 30, 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED, THAT THE SPRING JAMMED/STUCK INSIDE THE ANTERIOR REAMER SHAFT. THE SURGEON HAD TO ADJUST TO THE STUCK SPRING CAUSING HIM TO REAM 1MM TOO FAR ANTERIORLY. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 12554319 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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