Oxford Partial Knee System 159532Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05019279783144), received between Mar 22, 2020 and Mar 14, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 10 MONTHS POST INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO TIBIAL IMPLANT MALPOSITIONING. 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 21605577 ↗
• InjuryOct 2, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY AND APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO THE SUBSIDENCE OF THE TIBIAL COMPONENT. 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 17850206 ↗
• InjuryAug 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROSTHESES IMPLANTATION APPROXIMATELY SIX (6) YEARS AGO. ABOUT SIX (6) YEARS LATER PATIENT COMPLAINED OF KNEE PAIN, RESULTING IN REVISION SURGERY WITH EXCHANGING KNEE PROSTHESES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 17562675 ↗
• InjuryMar 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM AN OXFORD PARTIAL KNEE TO A VANGUARD TOTAL KNEE DO TO TIBIAL TRAY LOOSENING APPROXIMATELY EIGHT (8) YEARS AFTER INITIAL SURGERY. 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 16476617 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2016. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021. PATIENT OUTCOME: REVISION. ADDITIONAL INFORMATION: REASON FOR THE REVISION. LATERAL WEAR AND PAIN. OPERATIVE NOTES, BOTH INITIAL AND REVISION (AS APPLICABLE)? ALL THE PRE NOTES WERE SENT. NAME OF THE SURGEON WHO PERFORMED THE INITIAL PROCEDURE? SAME DOCTOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain

  MAUDE report 12968014 ↗
• 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 12524563 ↗
• InjuryMar 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO "OSTEONECROSIS OF THE FEMORAL CONDYLE IN THE LEFT KNEE" AND UNDERWENT "LEFT TOTAL KNEE ARTHROPLASTY". THE OPERATION WAS SUCCESSFUL AND THE PATIENT'S LIFE SIGNS WERE NORMAL ON OCTOBER 31ST.THE WOUND DRESSING WAS CLEAN. (B)(6) 2019 THE PATIENT CAME TO THE HOSPITAL AND REPORTED THAT HE STILL COULD NOT WALK NORMALLY OR STAND UPRIGHT, WHICH AFFECTED HIS LIFE. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND RECEIVED SYMPTOMATIC TREATMENT INCLUDING ANTI-INFLAMMATORY AND ANALGESIC THERAPY, PROMOTING BONE HEALING AND ANTI-OSTEOPOROSIS. TREATMENT: JOINT LOOSENING TRAINING ONCE BID, LEFT KNEE SANDBAG PRESSURE STRAIGHT QD; MEDICATION: 10MG ALENDRONATE SODIUM TABLET ORAL QD, 0.1G ALENDRONATE SODIUM TABLET ORAL BID, 240MG GLUCOSAMINE CAPSULE ORAL TID, 50MG TRAMADOL CAPSULE ORAL BID, 0.5G ALFA OSSIFICOL TABLET ORAL QD, 250ML SODIUM CHLORIDE INJECTION WITH 100MG BONE PEPTIDE INTRAVENOUS INFUSION QD, 250ML SODIUM CHLORIDE INJECTION WITH 24MG DEER AND GOURD POLYPEPTIDE INJECTION INTRAVENOUS INFUSION QD. OUTCOME: THE PATIENT SHOWED STABLE VITAL SIGNS, SIGNIFICANTLY RELIEVED THE PAIN OF THE LEFT KNEE JOINT, AND WAS DISCHARGED WITHOUT OBVI

  Patient problems: Discomfort; Pain

  MAUDE report 9863699 ↗

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

…and 7 more.