Oxford Partial Knee System 154724Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05019279388905), received between Aug 2, 2019 and Jun 4, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX YEARS AND SIX MONTHS AFTER THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A LEFT SIDED REPLACEMENT DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 19457916 ↗
• InjuryApr 15, 2024Unstable; Unstable

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

  Patient problems: Insufficient Information

  MAUDE report 19104016 ↗
• InjuryApr 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF UNICOMPARTMENTAL COMPONENTS THREE AND A HALF YEARS POST IMPLANTATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19078047 ↗
• InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNI KNEE ARTHROPLASTY AND APPROXIMATELY 7 MONTHS LATER A REVISION SURGERY WAS PERFORMED DUE TO THE FAILED IMPLANT ON TIBIAL SIDE. THERE WAS A VISIBLE CYST ABOUT THE SIZE OF A MARBLE TOWARD TO POSTERIOR ASPECT OF THE TIBIA THAT WAS MOSTLY CONTAINED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Cyst(s); Failure of Implant

  MAUDE report 18343136 ↗
• InjuryOct 16, 2023Loosening 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: Bone Fracture(s); Cyst(s); Pain

  MAUDE report 17938000 ↗
• InjuryAug 21, 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 DUE TO UNKNOWN REASON, APPROXIMATELY THREE (3) YEARS FROM THE INITIAL RIGHT KNEE ARTHROPLASTY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 17582276 ↗
• InjuryMay 19, 2023Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY YEAR AFTER PARTIAL LEFT KNEE ARTHROPLASTY PATIENT EXPERIENCED CRACKING, POPPING AND PAIN. BONE SCAN SHOWED LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 16960677 ↗
• InjuryMay 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Insufficient Information

  MAUDE report 16936966 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY AND APPROXIMATELY 5 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO PAIN. CONTRIBUTING FACTOR WAS DISEASE PROGRESSION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 16484003 ↗
• InjurySep 29, 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 SURGERY OF THE LEFT KNEE DUE TO LOOSENING, 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 15507735 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIBE EVENT OR PROBLEM. IT WAS REPORTED THAT THERE WAS A REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 13248207 ↗
• 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 10016770 ↗
• InjuryAug 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO SUBSIDENCE.

  Patient problems: No Code Available

  MAUDE report 8854309 ↗

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