Oxford Partial Knee System 154721Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05019279388875), received between Jun 5, 2019 and Jan 2, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL KNEE REVISION DUE TO UNKNOWN REASONS. APPROXIMATELY 7 YEARS 11 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23941893 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23630005 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY ONE YEAR AND TEN MONTHS POST IMPLANTATION, THEY UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Aseptic loosening; Bone Fracture(s); Insufficient Information; Pain

  MAUDE report 22381685 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20168467 ↗
• MalfunctionAug 14, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS FOUND THAT THE PLASTIC PACKAGING INSIDE THE CARTON WAS NOT SEALED, INDICATING THAT THE STERILE BARRIER HAD BEEN BREACHED AND COULD NOT BE USED ON THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. IT WAS EVENTUALLY CONFIRMED THAT INITIALLY, THE DISTRIBUTOR ACCIDENTALLY SENT THE HOSPITAL A PRODUCT WHICH THEY HAD ALREADY OPENED. THIS WAS CLARIFIED WITH THE HOSPITAL AND SURGEON. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE OR SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981271 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 19971372 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18969551 ↗
• InjuryDec 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 18396909 ↗
• InjuryDec 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THE EVENT IS A DUPLICATE OF (B)(4). THIS EVENT HAS BEEN REPORTED IN (B)(4). GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

  Patient problems: Failure of Implant

  MAUDE report 18354196 ↗
• InjuryJun 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT KNEE REVISION DUE TO LOOSENING OF TIBIAL COMPONENT APPROXIMATELY TWENTY (20) MONTHS AFTER INITIAL SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17058406 ↗
• InjuryApr 11, 2023Off-Label Use; Off-Label Use

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

  Patient problems: Insufficient Information

  MAUDE report 16711800 ↗
• InjuryApr 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION ON THEIR RIGHT SIDE FOR UNKNOWN REASONS, APPROXIMATELY FOUR (4) YEARS AFTER THE INITIAL SURGERY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16681001 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM AN OXFORD UNI TO A FULL KNEE DUE TO PATELLA PAIN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 15958110 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 YEARS AFTER KNEE IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN REASON. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15649368 ↗
• InjuryJul 22, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL KNEE REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT, APPROXIMATELY 10 MONTHS POST IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 15081652 ↗
• InjuryJun 8, 2022Mechanical Problem; Use of Device Problem; Device Dislodged or Dislocated; Mechanical Problem; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN INITIAL KNEE ARTHROPLASTY THE BEARING SPUN OUT AND FELL OFF TO THE POSTERIOR JOINT CAPSULE SIDE. THE SURGEON THEN DECIDED TO USE A DIFFERENT SYSTEM, AND THE FEMUR AND TIBIA COMPONENTS WERE REMOVED. DURING REMOVAL, THE PATIENT¿S FEMUR BONE CRACKED. SURGERY WAS DELAYED FOR ABOUT 40 MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 14629805 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASONS WAS PERFORMED ON (B)(6) 2022. OXFORD WARRANTY PHOTOS OF THE EXPLANTED ITEMS AND IMPLANTED ITEMS ARE IN THE FILES IN SMS ON THIS CASE. PATIENT INVOLVEMENT - NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 13577817 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12745165 ↗
• InjurySep 6, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED: THAT PATIENT UNDERWENT REVISION DUE TO TIBIAL LOOSENING. OXFORD KNEE SYSTEM WAS IMPLANTED ON THE RIGHT KNEE ON (B)(6) 2018 AND REVISED TO BE REPLACED WITH A PRESS-FIT KNEE SYSTEM ON (B)(6) 2021. NO FURTHER EVENT INFORMATION AVAILABLE AT TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 12427285 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2017. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016100 ↗
• InjurySep 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9063816 ↗
• InjurySep 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN AND BEARING DISLOCATION WAS PERFORMED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 8973986 ↗
• InjuryJun 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGERY DUE TO WOUND COMPLICATIONS.

  Patient problems: Wound Dehiscence

  MAUDE report 8669511 ↗

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-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-1152-2017 · Jan 5, 2016 · Terminated
  Oxford Knee System Tibial Resector Body Tube & Guides 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-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-1172-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Left 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-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-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-1170-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1156-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size F 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
• 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-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-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

…and 7 more.