Oxford Uni Knee System 32-422982Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05019279440030), received between Sep 24, 2021 and Jul 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation 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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Break1
- Compatibility Problem1
- Detachment of Device or Device Component1
- Fracture1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, A PIN FROM THE POSTERIOR CUTTING GUIDE ASSEMBLY DETACHED AND FELL FROM THE GUIDE. THERE WAS A SHORT DELAY TO RETRIEVE THE PIN. NOTHING WAS LEFT IN THE PATIENT. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE OR SERIOUS INJURY. HOWEVER, THERE WAS NO REPORT OF PATIENT HARM OR ANY FURTHER OUTCOME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688261 ↗MalfunctionSep 24, 2021Break; Fracture; Activation, Positioning or Separation Problem; Compatibility Problem; Material Integrity Problem; Break; Fracture; Activation, Positioning or Separation Problem; Compatibility Problem; Material Integrity Problem
IT WAS REPORTED THAT: DURING AN OXFORD PROCEDURE, WHEN THE SURGEON WAS TAPPING IN THE LARGE POSTERIOR RESECTION GUIDE, (32-422982), A SMALL METAL TIP CAME LOOSE FROM THE INSTRUMENT. THE SURGEON DISCOVERED IT IN THE WOUND, AND RETRIEVED IT BEFORE CLOSURE. THE NURSE WAS ABLE TO INSERT THE TIP INTO THE INSTRUMENT AGAIN. PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12525380 ↗
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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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