Oxford Uni Knee SystemRecalls & reported problems across all models
Biomet Uk Ltd · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 62
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 22 models of Oxford Uni Knee System by Biomet Uk Ltd in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Jul 1, 2019 and Jun 29, 2026 — classified as 5 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Fracture” (40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Oxford Uni Knee System problems
Device problems
- Fracture40
- Break10
- Material Integrity Problem9
- Detachment of Device or Device Component5
- Material Fragmentation4
- Mechanical Problem4
- Peeled/Delaminated3
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Foreign Body In Patient4
- No Consequences Or Impact To Patient4
- Insufficient Information3
- No Information1
Oxford Uni Knee System models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Oxford Uni Knee System 32-422822ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- Oxford® Uni Knee System 32-423228BIT, DRILL9 reports
- Oxford Uni Knee System 32-422760ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- Oxford Uni Knee System 32-422981ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- Oxford Uni Knee System 32-422805ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Oxford Uni Knee System 32-422806ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Oxford Uni Knee System 32-422845BIT, DRILL3 reports
- Oxford Uni Knee System 32-422807ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- Oxford Uni Knee System 32-422982ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- Oxford Uni Knee System 32-422801ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422811ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422812ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422767ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422808ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422809ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422863ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422978ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422979ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422980ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford Uni Knee System 32-422984ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford® Uni Knee System 32-423232ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Oxford® Uni Knee System 32-423233ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Oxford Uni Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, A PLASTIC FRAGMENT DETACHED FROM THE OXFORD XL DRILL GUIDE AND ENTERED THE SURGICAL SITE. THE DRILL GUIDE HAD ALREADY BEEN USED AND WAS NOT REQUIRED FOR THE REMAINDER OF THE PROCEDURE, ALLOWING SURGERY TO CONTINUE AS PLANNED. THE FRAGMENT WAS SUCCESSFULLY REMOVED DURING THE PROCEDURE. NO COMPLICATIONS, SERIOUS INJURY, OR DEATH WERE REPORTED. THE INSTRUMENT HAD BEEN USED APPROXIMATELY 50 TIMES BEFORE THE EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25649225 ↗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 ↗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 ↗InjuryDec 9, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23755660 ↗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 ↗MalfunctionOct 28, 2025Material Fragmentation; Material Fragmentation
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401031 ↗MalfunctionOct 28, 2025Material Fragmentation; Material Fragmentation
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401029 ↗MalfunctionAug 28, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22913455 ↗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 9, 2025Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn
IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, WHILE TESTING DIFFERENT POLYETHYLENE (PE) THICKNESSES, REPEATED USE OF THE THICKNESS GAUGE AGAINST THE INTERNAL TIBIAL TEST GAUGE GENERATED PLASTIC DEBRIS. ALL DEBRIS WAS SUCCESSFULLY RETRIEVED FROM THE JOINT WITH NO HARM TO THE PATIENT OR DELAY TO THE PROCEDURE. THE SURGICAL TECHNIQUE WAS PROPERLY FOLLOWED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22166071 ↗MalfunctionJun 9, 2025Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22166068 ↗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 ↗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 ↗MalfunctionMar 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663408 ↗MalfunctionMar 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663403 ↗
Other Biomet Uk Ltd products
All Biomet Uk Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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