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Oxford Partial Knee System 154720Recalls & 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
18
Deaths reported
0
Injuries reported
18
Recalls naming it
0

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05019279388868), received between Jul 3, 2019 and Jun 11, 2025 — classified as 18 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: 1 reportsJun 2024: 3 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 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 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem10
  • Insufficient Device Problem Information2
  • Loosening of Implant Not Related to Bone-Ingrowth2
  • Break1
  • Implant subsidence1
  • Inaccurate Delivery1
  • Unstable1

Patient problems

  • Insufficient Information8
  • Failure of Implant5
  • Pain4
  • No Information2
  • Abdominal Pain1
  • Bone Fracture(s)1
  • Impaired Healing1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 11, 2025Implant subsidence; Implant subsidence

    IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION SURGERY DUE TO SUBSIDENCE OF THE TIBIAL TRAY, APPROXIMATELY 3 MONTHS AND 2 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Patient problems: Failure of Implant

    MAUDE report 22182904 ↗
  • InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY 7 YEAR AND 5 MONTH POST IMPLANTATION, THE PATIENT UNDERWENT A LEFT SIDED REVISION FROM A PARTIAL KNEE TO A TOTAL KNEE DUE TO UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Insufficient Information

    MAUDE report 21250877 ↗
  • InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO TIBIAL PAIN. THE TIBIAL, BEARING AND FEMORAL COMPONENTS WERE REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Pain

    MAUDE report 20862829 ↗
  • InjuryJun 24, 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 19592752 ↗
  • InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER THE PATIENT UNDERWENT A UNICOMPARTMENTAL KNEE ARTHROPLASTY, THEY WERE REVISED DUE TO PAIN CAUSED BY TIBIAL BONE FRACTURE. THE SURGEON SPECULATES THAT AT THE TIME OF THE PRIMARY PROCEDURE, THERE MAY HAVE BEEN INSUFFICIENT REAMING OF THE FEMUR, WHICH POSSIBLY LED TO STRESS ON THE TIBIA CAUSING A FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Bone Fracture(s); Pain

    MAUDE report 19469635 ↗
  • InjuryJun 3, 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 19446677 ↗
  • InjuryMay 7, 2024Adverse 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 THE LEFT KNEE DUE TO UNKNOWN REASON APPROXIMATELY FIVE AND A HALF YEARS POST IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Insufficient Information

    MAUDE report 19258666 ↗
  • InjuryJul 11, 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 17296005 ↗
  • InjuryJun 12, 2023Unstable; Unstable

    UPON FURTHER ASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. GIVEN THIS INFORMATION, THIS MEDWATCH REPORT WILL BE VOIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17105864 ↗
  • InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT KNEE DUE TO ASEPTIC LOOSENING AND DISLOCATION OF MOBILE BEARING. 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 16270866 ↗
  • InjuryJan 27, 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 16251649 ↗
  • InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION OF PARTIAL TO TOTAL KNEE IMPLANT DUE TO UNKNOWN REASON, APPROXIMATELY 4 YEARS AFTER INITIAL IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 15698111 ↗
  • InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN 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 15500358 ↗
  • InjuryJun 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A REVISION DUE TO THE LOOSENING AND PAIN OF THE LEFT KNEE, APPROXIMATELY ONE YEAR 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; Pain

    MAUDE report 14561378 ↗
  • InjuryJun 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

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

    Patient problems: Insufficient Information

    MAUDE report 14560647 ↗
  • InjuryJul 20, 2020Break; Break

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT STATES TO HAVE BEEN REVISED DUE TO PAIN AND IMPLANT FAILURE. PATIENT STATED THE IMPLANT WENT BAD THREE TO FOUR MONTHS AFTER INITIAL SURGERY. IT HAD SHIFTED, DETERIORATED AND THE BOTTOM BONE WAS COMING OUT OF THE LET. PIECES OF THE DEVICE HAD SHREDDED.

    Patient problems: Abdominal Pain; Failure of Implant; Impaired Healing; Pain

    MAUDE report 10294568 ↗
  • InjuryOct 1, 2019Inaccurate Delivery; Inaccurate Delivery

    IT WAS REPORTED THAT A HOSPITAL ORDERED OXFORD TINOBIUM IMPLANTS, HOWEVER RECEIVED THE WRONG IMPLANTS. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH COMPETITORS PRODUCTS. ISSUE CAUSED 31-60 MINUTE DELAY.

    Patient problems: No Information

    MAUDE report 9138556 ↗
  • InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT A LEFT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO TIBIAL COMPONENT SUBSIDENCE AFTER A BICYCLE ACCIDENT.

    Patient problems: No Code Available; No Information

    MAUDE report 8758022 ↗

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

…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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