Oxford® Partial Knee System 32-422097Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00880304525672), received between Aug 7, 2020 and May 22, 2026 — classified as 7 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fracture” (30 reports).

22 other recalls cover devices cleared under the same FDA submission (P010014); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Fracture

  IT WAS REPORTED THAT AN INSTRUMENT BROKE AT THE TIP WHILE IN USE. THE BROKEN PORTION DID NOT CONTACT THE PATIENT, AND NO FRAGMENTS REMAINED. THE INSTRUMENT HAD BEEN USED APPROXIMATELY 40 TIMES, AND THE PROCEDURE EXPERIENCED A BRIEF DELAY OF APPROXIMATELY FIVE MINUTES WHILE THE INSTRUMENT WAS REPLACED. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253368 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION, THREE CEMENTLESS TIBIAL INSERTERS WERE IDENTIFIED TO BE DAMAGED. TWO INSERTERS HAD A FRACTURED METAL TIP, WHILE THE THIRD HAD A FRACTURED BLUE PLASTIC PAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878884 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION, THREE CEMENTLESS TIBIAL INSERTERS WERE IDENTIFIED TO BE DAMAGED. TWO INSERTERS HAD A FRACTURED METAL TIP, WHILE THE THIRD HAD A FRACTURED BLUE PLASTIC PAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878874 ↗
• MalfunctionNov 27, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664250 ↗
• InjuryNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A PORTION OF A TIBIAL IMPACTOR BROKE AND THE FRAGMENT REMAINED IN SITU. INTRA-OPERATIVELY, THE FRAGMENT WAS LEFT IN PLACE, NO REVISION SURGERY WAS PERFORMED, AND THERE WERE NO PLANS FOR REMOVAL OR FURTHER SURGICAL INTERVENTION OR FOLLOW-UP. THE PATIENT EXPERIENCED NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23508802 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402693 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402676 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642558 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY THE TIP OF THE TIBIAL INSERTER BROKE WHILE TRYING TO PUT THE DEFINITIVE TIBIA ON IT. NOTHING FELL INTO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217425 ↗
• MalfunctionMay 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIBIAL TRAY IMPACTOR WAS FOUND BROKEN AND UNUSABLE DURING SURGERY, AS IT COULDN¿T CONNECT TO THE IMPLANT. THE ISSUE WAS NOTICED WHEN IT WAS PICKED UP FROM THE TRAY. A FEMORAL IMPACTOR WAS USED INSTEAD, CAUSING A BRIEF 2-MINUTE DELAY. THE BROKEN INSTRUMENT DID NOT CONTACT THE PATIENT, AND NO FRAGMENTS WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068180 ↗
• 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 21662899 ↗
• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE OXFORD TIBIAL INSERTER BROKE OUT OF SURGERY. THE CLAMP FOOT THAT HOLDS THE TIBIAL IMPLANT BROKE OFF. NO HARM OR CONTACT WITH PATIENT. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617295 ↗
• MalfunctionJan 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AN OXFORD TIBIAL INSERTER WAS FOUND BROKEN, IT DOES NOT ENGAGE THE FINAL TIBIAL IMPLANT CORRECTLY. NO HARM TO PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139814 ↗
• MalfunctionJan 9, 2025Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112158 ↗
• InjuryOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SMALL LIP OF THE DEVICE (TIBIAL INTRODUCER) THAT ATTACHES TO THE IMPLANT FOR INSERTION BROKE OFF DURING IMPLANTATION. IT WAS NOT NOTICED UNTIL FOUND ON X-RAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20521013 ↗
• MalfunctionJun 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT TIBIA IMPLANT INSERTER TIP BROKE WHEN ENGAGING THE IMPLANT TO THE INSTRUMENT. 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. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592541 ↗
• MalfunctionJun 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP BROKE OFF THE IMPLANT INSERTER DURING THE SURGERY, NOT ENABLING IT TO BE USED. THE SURGEON PLACED THE IMPLANT DIRECTLY. 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.  NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496254 ↗
• MalfunctionOct 5, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876306 ↗
• InjurySep 7, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17696916 ↗
• MalfunctionJul 12, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305104 ↗
• InjuryJun 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL KNEE ARTHROPLASTY, THE POSTERIOR PART OF THE INSTRUMENT BROKE OFF AND WAS RETAINED IN THE PATIENT. A POST-OPERATIVE X-RAY CONFIRMED THE PRESENCE OF A SMALL METAL THREAD. HOWEVER, IT WAS REPORTED THAT THIS INCIDENT DID NOT CAUSE ANY HARM TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17070038 ↗
• 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 17069671 ↗
• InjuryJan 12, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16144640 ↗
• InjuryDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING SURGERY. THE BROKEN PIECE REMAINED IN THE PATIENT. ADDITIONAL SURGERY TO REMOVE THE INSTRUMENT'S BROKEN PIECE WAS PERFORMED THE NEXT DAY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15913816 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE IMPLANTATION, A SMALL PART OF THE INSTRUMENT BROKE OFF INSIDE THE PATIENT. THIS WAS ONLY DISCOVERED IN A POST-OP X-RAY. THE PATIENT WAS RETURNED TO THEATRE AND THE SURGEON REMOVED THE REMNANTS OF THE INSTRUMENT.DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15238961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010014. One submission often covers many models, so check the product and lot details in each record.

• Z-1155-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1165-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
• Z-1164-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1162-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1157-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1169-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1158-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1153-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1171-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1159-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1173-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1160-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1168-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1154-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1161-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System

…and 7 more.