OXFORD UNICOMPARTMENTAL KNEE PHASE 3TIBIAL IMPACTOR 32-420932Recalls & reported problems
Biomet Uk Ltd · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05019279905638), received between Jun 24, 2022 and Sep 28, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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
- Fracture17
- Break1
- Crack1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fracture
It was reported that the black impactor piece is broken. They flagged it before the start of the surgery. The broken impactor did not contact the patient. Over 100 instruments were used before the reported failure. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912420 ↗MalfunctionFeb 9, 2026Fracture
IT WAS REPORTED THAT DURING TIBIAL IMPACTION, A PIECE OF THE BLACK PLASTIC BROKE OFF THE IMPACTOR. THE EVENT OCCURRED INTRA-OPERATIVELY DURING TIBIAL PREPARATION WHILE THE IMPACTOR WAS BEING USED. THERE WAS NO HARM TO THE PATIENT, NO FOREIGN BODY WAS RETAINED. 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 24289482 ↗MalfunctionDec 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIBIAL LID OF AN IMPACTOR BROKE DURING USE AND NO FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23801131 ↗MalfunctionOct 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR BROKE DURING SURGERY. THERE WAS NO IMPACT ON THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23345421 ↗MalfunctionOct 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23280039 ↗MalfunctionMay 23, 2025Fracture; Fracture
THE SCREW THAT KEEPS THE BLACK IMPACTOR PAD ON THE IMPACTOR BROKE WHILE ASSEMBLING PRE-OP. NOTHING FELL IN THE PATIENT. NO FOLLOW-UP WAS INITIATED AS ALL REQUIRED INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22076685 ↗MalfunctionSep 12, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20198782 ↗MalfunctionApr 8, 2024Crack; Crack
IT WAS REPORTED THAT DURING A KIT INSPECTION, IT WAS NOTICED THAT THE TIBIAL PUNCH PLASTIC COVER CRACKED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT INVOLVEMENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059076 ↗MalfunctionMar 26, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980259 ↗MalfunctionMar 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON BROKE THE BOLT OF THE TIBIAL IMPACTOR. NO PIECE FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY COMPLICATIONS. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920346 ↗MalfunctionJan 15, 2024Break; Break
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18510400 ↗MalfunctionJan 8, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18462540 ↗MalfunctionDec 18, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18343146 ↗MalfunctionOct 31, 2023Fracture; Fracture
IT WAS REPORTED THAT THE BLACK IMPACTOR PAD BROKE DURING IMPACTION, NO PIECES FELL INTO PATIENT, IMPLANT PROPERLY SEATED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. ALL THE AVAILABLE INFORMATION HAS BEEN CAPTURED IN THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18037798 ↗MalfunctionAug 29, 2023Fracture; Fracture
IT WAS REPORTED THAT A SMALL LOCKING KNOB BROKE OFF WHILE IMPACTING THE IMPLANT INTO PLACE. 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 17641130 ↗MalfunctionJun 6, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PARTIAL LEFT KNEE ARTHROPLASTY THAT THE INSTRUMENT FRACTURED. NO PIECE FELL NOR REMAIN INTO THE PATIENT BODY. ALL PIECES WERE FOUND. NO IMPACT OR INJURY TO PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17069670 ↗MalfunctionMay 9, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894020 ↗MalfunctionAug 18, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING SURGERY THE BLACK TIP OF THE TIBIAL IMPACTOR BROKE. NO INFORMATION ABOUT PATIENT HARM HAS BEEN REPORTED. 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 15247150 ↗MalfunctionJul 27, 2022Fracture; Fracture
IT WAS REPORTED THAT THE BLACK PLASTIC IMPACTOR TIP SPLIT IN A HALF UPON IMPACTION. NO KNOWN HARM OR CONSEQUENCES TO THE PATIENT. 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 15110822 ↗MalfunctionJun 24, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PIN THAT HOLDS THE BLACK PAD BROKE DURING IMPACTION. THE EVENT OCCURRED DURING SURGERY AND NO HARM TO THE PATIENT IS REPORTED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SAME DEVICE. NO FURTHER PATIENT OUTCOME PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14796581 ↗
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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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