Oxford® Partial Knee System 166575Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887868354748), received between Jul 7, 2022 and Aug 29, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Periprosthetic fracture

  MAUDE report 22920982 ↗
• InjuryJul 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY TEN WEEKS POST-IMPLANTATION, THE PATIENT REQUIRED A REVISION SURGERY DUE TO A TIBIAL BONE FRACTURE, WHICH WAS ATTRIBUTED TO THE LOOSENING OF THE TIBIAL IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Periprosthetic fracture

  MAUDE report 22413320 ↗
• MalfunctionJul 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT, AN EYELASH WAS NOTICED IN THE STERILE PACKAGING. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, IN THIS CASE NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674462 ↗
• InjuryMar 18, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN INITIAL RIGHT MEDIAL KNEE UNICONDYLAR ARTHROPLASTY APPROXIMATELY ONE YEAR AGO. A MONTH AGO THE PATIENT WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY DUE TO PERSISTENT PAIN AND MALALIGNMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 18920193 ↗
• InjuryOct 2, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TIBIAL CEMENTLESS BASE PLATE IS LARGER THAN THE ACTUAL DIMENSIONS INDICATED ON THE LABEL, AND THE CEMENTLESS BASE PLATE WITH A LARGER DIMENSION THAN INDICATED MAY HAVE BEEN USED, RESULTING IN A SERIES OF TIBIAL FRACTURES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis

  MAUDE report 17850413 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE KNEE PAIN AND STIFFNESS APPROXIMATELY FOUR MONTHS AFTER UNICONDYLAR KNEE ARTHROPLASTY. THIS WAS TREATED WITH A CORTISONE INJECTION IN THE KNEE. THE PAIN AND STIFFNESS PERSISTED UNTIL THREE MONTHS LATER WHEN A PARAPATELLAR EFFUSION WAS ASPIRATED. FOLLOWING THE ASPIRATION, THE PATIENT CONTINUED TO SHOW IMPROVEMENT IN PAIN AND FUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17640607 ↗
• InjuryJul 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM A PARTIAL KNEE TO A TOTAL KNEE DUE TO TIBIAL COLLAPSE, APPROXIMATELY TWO (2) MONTHS 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 14942470 ↗

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

…and 7 more.