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Oxford Partial Knee System 159531Recalls & reported problems

Biomet Uk Ltd · Class 3 · Implant

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05019279783137), received between Sep 30, 2020 and Aug 21, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 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 Problem5
  • Loosening of Implant Not Related to Bone-Ingrowth2

Patient problems

  • Failure of Implant4
  • Pain2
  • Insufficient Information1
  • No Information1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 21, 2024Loosening 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 20023006 ↗
  • InjuryMar 18, 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 18919853 ↗
  • InjuryDec 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNICOMPARTMENTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE IMPLANT. 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 18362180 ↗
  • InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION 27 MONTHS POST-IMPLANTATION DUE TO PAIN. 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 15402109 ↗
  • InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A REVISION OF LEFT KNEE DUE TO UNKNOWN REASONS, APPROXIMATELY TWO (2) YEARS POST-OP. 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 15182471 ↗
  • InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2017. SUBSEQUENTLY, WAS REVISED DUE TO PAIN AND HEMARTHROSIS ON (B)(6) 2021.

    Patient problems: Pain

    MAUDE report 12098327 ↗
  • InjurySep 30, 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 KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO LATERAL WEAR.

    Patient problems: No Information

    MAUDE report 10604742 ↗

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

…and 7 more.

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.