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Oxford Partial Knee System 154725Recalls & reported problems

Biomet Uk Ltd · Class 3 · Implant

All models of Oxford Partial Knee System (92)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
15
Deaths reported
0
Injuries reported
15
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05019279388912), received between Jul 4, 2019 and Apr 16, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem7
  • Insufficient Device Problem Information2
  • Loosening of Implant Not Related to Bone-Ingrowth2
  • Noise, Audible2
  • Device Dislodged or Dislocated1
  • Mechanical Problem1
  • Migration1
  • No Apparent Adverse Event1

Patient problems

  • Insufficient Information6
  • Pain6
  • Failure of Implant3
  • Loss of Range of Motion2
  • Ambulation or Postural Difficulties1
  • Arthritis1
  • Inflammation1
  • No Code Available1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF A PARTIAL RIGHT KNEE TWO YEARS AND FIVE MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 21846477 ↗
  • InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

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

    Patient problems: Arthritis; Insufficient Information

    MAUDE report 20650330 ↗
  • InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE A DUPLICATE OF MFR REPORT NUMBER 3002806535-2023-00194. HENCE THIS REPORT SHOULD BE VOIDED.

    Patient problems: Insufficient Information

    MAUDE report 17246875 ↗
  • InjuryMay 25, 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 17000812 ↗
  • InjuryMay 19, 2023Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT APPROXIMATELY YEAR AFTER PARTIAL RIGHT KNEE ARTHROPLASTY PATIENT EXPERIENCED CRACKING, POPPING AND PAIN. BONE SCAN SHOWED LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; Pain; Radiolucent Lines

    MAUDE report 16960891 ↗
  • InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY SIX YEARS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT REVISION FROM PARTIAL TO TOTAL KNEE PROSTHESIS. 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 15232043 ↗
  • InjuryJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT KNEE APPROXIMATELY THREE (3) MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING AND LIMITATION OF MOVEMENT AFTER EXTREME FLEXION OF THE KNEE. 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 15052343 ↗
  • InjuryJun 13, 2022Migration; Migration

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO SUBSIDENCE WAS PERFORMED, APPROXIMATELY SIX (6) YEARS POST-OP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

    MAUDE report 14673777 ↗
  • InjurySep 1, 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), 2016. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN WAS PERFORMED ON (B)(6), 2021. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: Pain

    MAUDE report 12406919 ↗
  • InjuryApr 20, 2021Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6), 2018. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO SUBSIDED TIBIAL COMPONENT WAS PERFORMED ON (B)(6) 2021.

    Patient problems: Insufficient Information

    MAUDE report 11691858 ↗
  • InjuryFeb 25, 2021Mechanical Problem; Structural Problem; Mechanical Problem; Structural Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE OXFORD PKR TIBIA WAS REVISED FOR INSTABILITY ON (B)(6) 2021.

    Patient problems: Insufficient Information

    MAUDE report 11378451 ↗
  • 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 10378439 ↗
  • InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED BY THE PATIENTS LEGAL COUNSEL THAT THE PATIENT SUFFERED UNKNOWN MEDICAL CONDITION POST OXFORD PARTIAL KNEE ARTHROPLASTY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Patient problems: No Code Available

    MAUDE report 8892744 ↗
  • InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED SEVERE PAIN CONSTANTLY WITH SOME INSTABILITY.

    Patient problems: Pain

    MAUDE report 8821444 ↗
  • InjuryJul 4, 2019Noise, Audible; Noise, Audible

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT RIGHT KNEE ATHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT ARTHROTOMY AND DEBRIDEMENT DUE TO EXPERIENCING PAIN, POPPING/CLICKING AND CATCHING OF RIGHT KNEE. SURGEON FURTHER REPORTED ENTRAPPED AND INFLAMED SYNOVIUM TISSUE, AS WELL AS A SMALL AMOUNT OF HO BONE WAS EXCISED. FOLLOW-UP APPOINTMENT POST PROCEDURE REPORTED SYMPTOMS WERE NO LONGER PRESENT.

    Patient problems: Inflammation; Pain

    MAUDE report 8762253 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 7 more.

Other Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing devices

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Sources and updates

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