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Oxford Partial Knee System 160791Recalls & reported problems

Biomet Uk Ltd · Anatomic Meniscal Bearing Right Medial · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05019279073023), received between Sep 24, 2021 and May 15, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (3 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: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 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: 1 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

  • Naturally Worn3
  • Device Dislodged or Dislocated2
  • Mechanical Problem1
  • Patient Device Interaction Problem1
  • Use of Device Problem1

Patient problems

  • Failure of Implant2
  • Pain2
  • Bone Fracture(s)1
  • Loss of Range of Motion1
  • No Clinical Signs, Symptoms or Conditions1
  • Swelling/ Edema1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 15, 2025Naturally Worn; Naturally Worn

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22028881 ↗
  • InjuryMay 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AND SEVEN MONTHS POST INITIAL IMPLANTATION, THE PATIENT UNDERWENT A RIGHT SIDED KNEE REVISION DUE TO JOINT INSTABILITY. THE SURGEON SUSPECTS BEARING WEAR AS THE CAUSE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Failure of Implant

    MAUDE report 19389683 ↗
  • 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 15052326 ↗
  • 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 14629800 ↗
  • InjurySep 24, 2021Naturally Worn; Patient Device Interaction Problem; Naturally Worn; Patient Device Interaction Problem

    IT WAS REPORTED THAT: UKA WAS PERFORMED WITH OXFORD ON (B)(6), 2018. POSTOPERATIVELY, THE PATIENT WHO UNDERWENT THE INITIAL OPERATION FELT A PAIN TO SEE A DOCTOR. AT THE DIAGNOSIS, TIBIAL TRAY SINKING WAS CONFIRMED. A REVISION WAS PERFORMED TO REPLACE THE TIBIAL TRAY, BEARING AND FEMORAL COMPONENT ON (B)(6) 2021. AT THE REVISION, THE SURGEON CONFIRMED WEAR ON THE EXPLANTED BEARING. PATIENT INVOLVED.

    Patient problems: Pain

    MAUDE report 12524565 ↗

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

…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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