Oxford Partial Knee System 159578Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05019279786244), received between Apr 7, 2020 and Jan 12, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A FRACTURED KNEE BEARING IMPLANT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24035194 ↗
• 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 18920195 ↗
• InjuryJan 16, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 18516064 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT FOUR DAYS AFTER REVISION SURGERY OF POLYETHYLENE BEARING DUE TO DISLOCATION, THE PATIENT DEVELOPED SUPERFICIAL CELLULITIS OF THE KNEE. AN ASPIRATION OF THE KNEE WAS PERFORMED SIX DAYS LATER. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Cellulitis

  MAUDE report 18039850 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT FOUR DAYS AFTER REVISION SURGERY OF POLYETHYLENE BEARING DUE TO DISLOCATION, THE PATIENT DEVELOPED SUPERFICIAL CELLULITIS OF THE KNEE. AN ASPIRATION OF THE KNEE WAS PERFORMED SIX DAYS LATER. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Cellulitis

  MAUDE report 18039595 ↗
• InjuryOct 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO SWAP KNEE BEARING APPROXIMATELY THREE YEARS POST INITIAL IMPLANTATION DUE TO BEARING DISLOCATION WHILE BENDING OVER IN THE YARD. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Joint Dislocation; Pain; Swelling/ Edema

  MAUDE report 17874896 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 17000815 ↗
• InjuryJun 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY SURGERY AND APPROXIMATELY 4.5 YEARS LATER THE RIGHT MOBILE BEARING WAS REVISED DUE TO PAIN AND INSTABILITY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 14617584 ↗
• InjurySep 27, 2021Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  15 SEP 2021 IT WAS REPORTED, THAT: "IMPLANT EXPIRED 2/9/21 WAS IMPLANTED BY CUSTOMER (B)(6) 2021". PATIENT INVOLVEMENT. ADDI 24 SEP 2021 (B)(6) THE CLINICAL SUPPORT PROVIDED THE FOLLOWING INFORMATION :- THE IMPLANT WAS ON THE OOD LIST AND THE HOSPITAL AWARE. THE MEMBER OF STAFF WHO MANAGES THIS HAD BEEN OFF SICK AND THE IMPLANT STILL ON THE SHELF. THE TIME LINE WAS WITHIN THE MONTH PERIOD (B)(6) SAYS HE HAS BEEN SET TO REMOVE OOD¿S. THE IMPLANT WAS ERRONEOUSLY IMPLANTED AS THE STAFF DID NOT READ THE DAY/MONTH/YEAR, READING ONLY MONTH AND YEAR. (B)(6) AS OF 17TH SEPT WAS UNAWARE OF THE EVENT BEING LABELLED ADVERSE BY THE HOSPITAL BUT AN INVESTIGATION IS ONGOING INTO THE EVENT. WE (QARA) AS WE ALREADY EXPLAINED TO (B)(6), ARE RAISING A CAPA. ADDI 27 SEP 2021 THIS WAS A CONSIGNMENT ITEM. THE DISCOVERY WAS MADE POST OPERATION. THERE WAS NO DELAY IN SURGERY. + PICTURE ATTACHED ADDI 14 OCT 2021 LEGAL LETTER TO COMPLAINANT SENT BY (B)(6) TO (B)(6) MAILBOX.

  Patient problems: Insufficient Information

  MAUDE report 12532349 ↗
• InjuryAug 31, 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 BI-LATERAL KNEE ARTHROPLASTY ON (B)(6)2018. SUBSEQUENTLY, A REVISION PROCEDURE ON THE RIGHT KNEE DUE TO PAIN AND WEAR WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12390609 ↗
• InjurySep 4, 2020Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. AN OXFORD BEARING WAS REMOVED DUE TO DISLOCATION. THE BEARING WAS REMOVED THREE DAYS AFTER DISLOCATION. UPON REMOVAL THE SURGEON NOTICED UNUSUAL "PITTING" AND WEAR ALONG THE UNDERSIDE OF THE POLY. THIS WAS A CAUSE FOR CONCERN CONSIDERING THE PATIENT WAS ONLY 6 MONTHS POST OP.

  Patient problems: Joint Dislocation; No Information

  MAUDE report 10492831 ↗
• InjuryApr 7, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE BEARING WAS REVISED DUE TO UNKNOWN REASON

  Patient problems: Joint Dislocation; No Information

  MAUDE report 9932485 ↗

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

…and 7 more.