Oxford Partial Knee System 161471Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05019279438266), received between Jul 1, 2019 and Nov 9, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 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) 2018. SUBSEQUENTLY, A TOTAL KNEE REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12778718 ↗
• InjuryAug 24, 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) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PATIENT PAIN AND LATERAL PROGRESSION WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12358922 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT INITIAL LEFT UNICOMPARTMENTAL OXFORD KNEE ARTHROPLASTY ON (B)(6) 2019. HE HAS SINCE EXPERIENCED PAIN AND BEEN UNABLE TO STRAIGHTEN HIS KNEE SINCE THE SURGERY. TREATMENT RECEIVED BY THE PATIENT INCLUDE, PHYSICAL THERAPY ON (B)(6) 2020 AND AN INJECTION ON (B)(6) 2020. THE OUTCOME WAS NOTED AS TOLERATED. THE EVENT IS NOT DEVICE RELATED. THE CLINICAL STUDY GROUP IDENTIFIED THE EVENT, HOWEVER, THE PATIENT LEFT KNEE WAS NOT ENROLLED IN THE CLINICAL STUDY.

  Patient problems: Pain

  MAUDE report 10697035 ↗
• InjuryJun 10, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON COMPLETION OF PREPARATION OF THE KNEE ANATOMY FOR IMPLANTATION, DESIRED IMPLANTS WERE OPENED. OUTER PACKAGING ALL APPEARED INTACT BUT UPON OPENING OF OXFORD X-LARGE FEMORAL IMPLANT IT WAS NOTICED THAT THE INNERMOST PLASTIC PACKAGING WAS SEVERLY COMPROMISED AND THE IMPLANT HAD RETAINED WEAR AND DEBRIS. AT THIS TIME THE IMPLANT WAS REMOVED FROM STERILE FIELD AND A REPLACEMENT IMPLANT WAS SOURCED AND USED WHICH CAUSED A 45 MINUTE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136895 ↗
• MalfunctionSep 9, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE VACUUMED SEALED STERILE PACKAGE HAD A HOLE IN THE PLASTIC, ANOTHER DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8974263 ↗
• MalfunctionJul 1, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE HOSPITAL THAT THE INNER STERILE PACKING OF XL CEMENTED OXFORD TWIN PEG FEMORAL HAD A DEFECT. SUBSEQUENTLY, AN ALTERNATIVE STERILE IMPLANT WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748064 ↗

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

…and 7 more.