Oxford Uni Knee System 32-422845Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304504714), received between Aug 5, 2020 and Feb 3, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE FRACTURED INTO TWO PIECES DURING DRILLING. NO FOREIGN MATERIAL WAS RETAINED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE INSTRUMENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES OR HEALTH IMPACTS TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244135 ↗MalfunctionMay 22, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069302 ↗MalfunctionAug 5, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING SURGERY, THE OXFORD FEMORAL DRILL WAS FOUND NOT TO BE IN WORKING ORDER. EVERYTHING THAT IS SUPPOSED TO PINCH OR BE STUCK IN THE (THICK) LOWER BOREHOLE FEMORAL OXFORD SHAKES AND TENDS TO NOT PINCH (TRIAL FEMUR) OR FALLS OUT (SPIGOTS). THE ASSUMPTION IS THAT THE INSTRUMENT HAS BEEN USED MANY TIMES, SO THE OPENING OF THE DRILL HAS BECOME LOOSE. NO IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER. NO DELAY OF THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10366278 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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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