Oxford® Uni Knee System 32-423228Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304504707), received between Jul 25, 2022 and Dec 18, 2025 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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
- Fracture8
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23837075 ↗MalfunctionDec 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BIT BROKE FOLLOWING DRILLING. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE BROKEN TIP BRIEFLY REMAINED WITHIN THE BONE BUT WAS COMPLETELY REMOVED WITHOUT ISSUE. THERE WAS NO HEALTH IMPACT TO EITHER THE PATIENT OR THE OPERATOR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704853 ↗MalfunctionJun 27, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, A DRILL BROKE WITHIN THE DRILL GUIDE. NO DEBRIS FELL OR REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER SET. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343894 ↗MalfunctionJun 3, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRILL WAS FRACTURED DURING SURGERY. THERE WAS NO HARM TO THE PATIENT. SURGERY WAS COMPLETED WITH ALTERNATIVE DEVICE WITH A DELAY OF THIRTY MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22130185 ↗MalfunctionDec 13, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL FRACTURED. NO PIECE WAS LEFT IN THE PATIENT. THERE WERE NO REPORTED HEALTH IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20923348 ↗MalfunctionApr 26, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19189495 ↗MalfunctionNov 24, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18204525 ↗MalfunctionSep 12, 2022Break; Break
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15400923 ↗MalfunctionJul 25, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING USE IN THE DRILL GUIDE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15091770 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page