Oxford Partial Knee System 159575Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05019279786213), received between Jul 24, 2019 and Feb 18, 2025 — classified as 28 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 17, 2020Terminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2148-2020 · Root cause: Process control · FDA record ↗

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.

• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BEARING EXCHANGE ON THE RIGHT KNEE TEN YEARS AND NINE MONTHS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21401023 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20819604 ↗
• InjuryOct 28, 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: Insufficient Information; Pain

  MAUDE report 20546245 ↗
• InjuryAug 12, 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: Insufficient Information

  MAUDE report 19959128 ↗
• InjuryJul 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BEARING FRACTURE, APPROXIMATELY 9 YEARS AND 6 MONTHS POST-IMPLANTATION. A NEW BEARING WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 19738733 ↗
• MalfunctionJun 20, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573631 ↗
• MalfunctionJun 20, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573628 ↗
• InjuryApr 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE RIGHT KNEE DUE TO BEARING DISLOCATION APPROXIMATELY SIX MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 19211403 ↗
• InjuryApr 16, 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: Fall; High White Blood Cell Count

  MAUDE report 19114596 ↗
• InjuryApr 8, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 19058278 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE KNEE PAIN AND STIFFNESS APPROXIMATELY FOUR MONTHS AFTER UNICONDYLAR KNEE ARTHROPLASTY. THIS WAS TREATED WITH A CORTISONE INJECTION IN THE KNEE. THE PAIN AND STIFFNESS PERSISTED UNTIL THREE MONTHS LATER WHEN A PARAPATELLAR EFFUSION WAS ASPIRATED. FOLLOWING THE ASPIRATION, THE PATIENT CONTINUED TO SHOW IMPROVEMENT IN PAIN AND FUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17640490 ↗
• InjuryJul 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS POST INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY FOR A KNEE BEARING DISLOCATION AFTER A FALL. ATTEMPTS HAVE BEEN PERFORMED AND NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 17340653 ↗
• InjuryApr 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Failure of Implant

  MAUDE report 16805159 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL UNI KNEE ARTHORPLASTY AND APPROXIMATELY 9 (NINE) YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO LATERAL WEAR AND PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 16767985 ↗
• InjuryFeb 3, 2023Adverse 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: Insufficient Information

  MAUDE report 16288998 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO PAIN, APPROXIMATELY NINE (9) YEARS THREE (3) MONTHS AFTER INITIAL SURGERY. TOTAL KNEE CONVERSION WAS PERFORMED DURING THE REVISION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15842885 ↗
• 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 15649357 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED FROM AN OXFORD UNI TO A TOTAL KNEE DUE TO UNKNOWN REASONS.

  Patient problems: Failure of Implant

  MAUDE report 15508348 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY AND DEVELOPED INFECTION WITHIN THE SAME YEAR. REVISION SURGERY WAS PERFORMED AND THE BEARING WAS CHANGED. INVESTIGATION RESULTS ARE NOW AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 14942310 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PARTIAL KNEE ARTHROPLASTY SURGERY WAS PERFORMED AND APPROXIMATELY 6 YEARS LATER THE PATIENT IS STILL EXPERIENCING INTERMITTENT PAIN AND SWELLING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain; Synovitis

  MAUDE report 14926773 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: PATIENT WAS SEEN IN CLINIC ON (B)(6) 2021 COMPLAINING OF PAIN ON HER RIGHT PES ANSERINUS BURSA SITE. THIS ISSUE WAS FIRST NOTED ON (B)(6) 2019 AND WAS REPORTED IN (B)(4). PER VISIT NOTE FROM ON (B)(6) 2021, IMPLANT IS IN GOOD POSITION, THERE WERE NO EVIDENCE OF FRACTURE/LYSIS/WEAR/SUBSIDENCE. PATIENT WAS PRESCRIBED NSAIDS AND WILL BE SEEN FOR A FOLLOW-UP ON (B)(6) 2021. ADDI ON (B)(6) 2021:

  Patient problems: Pain

  MAUDE report 12638097 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING A PRIMARY TOTAL HIP REPLACEMENT AND A REVISION OF AN OXFORD UNICOMPARTMENTAL KNEE REPLACEMENT ON THE SAME SIDE (RIGHT). THE PATIENT HAD ISSUES OF PAIN AND INFLAMMATION ON THE RIGHT KNEE, HENCE HE DECIDED TO HAVE IT REVISED AT THE SAME TIME AS HIS HIP.

  Patient problems: Inflammation; Pain

  MAUDE report 12566960 ↗
• InjuryAug 4, 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 KNEE ARTHROPLASTY ON (B)(6) 2021. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12272717 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MYMOBILITY CLINICAL STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL PARTIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED PES BURSA WHICH ONSET ON (B)(6) 2021. THE SEVERITY WAS REPORTED AS MILD. TREATMENT: STEROID INJECTION. NOT DEVICE RELATED. POSSIBLY PROCEDURE RELATED.

  Patient problems: Swelling/ Edema

  MAUDE report 11965376 ↗
• InjuryAug 7, 2020Adverse 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. SUBSEQUENTLY, THE PATIENT BEGAN EXHIBITING PAIN DURING NORMAL RANGE OF MOTION WHICH RESULTED IN A REVISION PROCEDURE.

  Patient problems: Pain

  MAUDE report 10378445 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-1163-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size D 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

…and 7 more.