Oxford Partial Knee System 154635Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05019279388400), received between May 1, 2020 and Feb 6, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY TWENTY YEARS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BEARING FRACTURE. 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 18648488 ↗
• InjuryMay 1, 2020Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY IN 2004. SUBSEQUENTLY, THE PATIENT CLAIMS TO BE SUFFERING FROM LOSS OF RANGE OF MOTION, INSTABILITY, HYPEREXTENSION, PAIN AND HAS TO USE A CANE TO WALK. THE REVISION IS SCHEDULED FOR (B)(6) 2020, BUT OF THAT MAY CHANGE DUE TO THE CURRENT SITUATION WITH COVID-19. INFORMATION RECEIVED STATING THAT THE REVISION SURGERY TOOK PLACE ON (B)(6) 2020.

  Patient problems: Ambulation or Postural Difficulties; High Blood Pressure/ Hypertension; Loss of Range of Motion; Pain

  MAUDE report 10016771 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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.