Oxford Partial Knee System 154601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05019279388073), received between Jul 2, 2019 and Jun 9, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO FRACTURED FEMORAL COMPONENT WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11964240 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2019. THE PATIENT PRESENTED WITH PAIN AND AS A RESULT AN ARTHROSCOPY WITH ASPIRATION TO RULE OUT INFECTION AND CONFIRM IMPLANT LOOSENING WAS CARRIED OUT ON (B)(6) 2020, AND SYNOVASURE TEST WAS PERFORMED. THE RESULT IS LOOSE FEMORAL COMPONENT. CONFIRMED BY ARTHROSCOPY. SAMPLES TAKEN, SYNOVASURE NEGATIVE AND NO ORGANISM GROWN. CEMENT WAS FOUND TO HAVE GOOD BOND TO THE IMPLANT AND INTERDIGITATION INTO THE BONE. SUBSEQUENTLY, REVISION SURGERY WAS CARRIED ON (B)(6) 2020 DUE TO LOOSE FEMORAL COMPONENT. IT WAS ALSO NOTED BY THE SURGEON THAT A LUCENT LINE WAS VISIBLE ON X-RAY.

  Patient problems: No Code Available; Pain

  MAUDE report 10361032 ↗
• InjuryJul 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS SCHEDULED TO BE REVISED DUE PAIN AND KNEE LOCKING UP.

  Patient problems: No Information; Pain

  MAUDE report 8751943 ↗

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

…and 7 more.