Oxford Partial Knee System 159540Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05019279785865), received between Mar 17, 2020 and Jan 30, 2026 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 24220355 ↗
• InjuryDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23743433 ↗
• InjuryOct 22, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

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

  Patient problems: Pain

  MAUDE report 23356111 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF THE LEFT KNEE DUE TO LATERAL PROGRESSION TWO AND A HALF YEARS POST IMPLANTATION. FURTHER REVIEW OF RADIOGRAPHS RECEIVED IDENTIFIED A MEDIAL COMPARTMENT HEMI ARTHROPLASTY WITH LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AS WELL AS NARROWING SUGGESTING POLYETHYLENE WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21729189 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION SURGERY DUE TO ASEPTIC LOOSENING, APPROXIMATELY 11 MONTHS POST-IMPLANTATION. 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 21398065 ↗
• InjuryOct 2, 2024Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20352587 ↗
• InjuryJul 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 19750413 ↗
• InjuryJun 24, 2024Adverse 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 19592754 ↗
• InjuryMay 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON THE LEFT KNEE DUE TO BEARING FRACTURE TEN YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19266664 ↗
• InjuryApr 9, 2024Adverse 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 19069187 ↗
• InjuryDec 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNICOMPARTMENTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE IMPLANTS. 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 18362171 ↗
• InjuryOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE BEARING (INSERT). 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 17893914 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION FROM PARTIAL TO TOTAL KNEE PROSTHESIS DUE TO UNKNOWN REASON. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15975335 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION OF PARTIAL TO TOTAL KNEE IMPLANT DUE TO UNKNOWN REASON, APPROXIMATELY 4 YEARS AFTER INITIAL IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15698134 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL OXFORD UNI KNEE SURGERY. APPROXIMATELY 5 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE PAIN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 15602768 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN REVISED DUE TO REOCCURRING HEMARTHROSIS APPROXIMATELY 3.5 YEARS AFTER THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14734099 ↗
• InjuryMay 30, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 8 MONTHS AFTER THE IMPLANTATION DUE TO PAIN AND METAL ALLERGY. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 14539613 ↗
• InjuryOct 1, 2021Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT OXFORD MOBILE BEARING IMPLANTS WERE REVISED TO A VANGUARD TOTAL KNEE. THE TIBIAL TRAY IMPLANT APPEARED TO BE LOOSE WHEN TAKING THE PARTS OUT. PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 12559743 ↗
• InjuryMay 20, 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 LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2021 THE PATIENT ATTENDED THE PHYSICIAN¿S OFFICE DUE TO STIFFNESS, POSTEROLATERAL KNEE PAIN, PAIN WITH EXTENSION, AND BUCKLING. THE SYMPTOMS WERE TREATED WITH A CORTISONE INJECTION.

  Patient problems: Pain

  MAUDE report 11853840 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MYMOBILITY CLINICAL STUDY: PROSPECTIVE MULTICENTER LONGITUDINAL COHORT STUDY INCLUDING AN INTERVENTIONAL (SOC) RCT SUB-STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020 THE PATIENT ATTENDED THE PHYSICIAN'S OFFICE DUE TO BLEEDING FROM THE INCISION AREA. DIAGNOSIS WAS EFFUSION OF THE LEFT KNEE JOINT, WHICH WAS TREATED WITH ASPIRATION OF THE KNEE JOINT 2 DAYS LATER. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11840067 ↗
• InjuryJan 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INITIAL LEFT UNILATERAL TKA WAS PERFORMED ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT HAD A MANIPULATION UNDER ANAESTHESIA (MUA) ON (B)(6) 2020 DUE TO STIFFNESS AND LIMITED MOBILITY.

  Patient problems: Loss of Range of Motion

  MAUDE report 11228852 ↗
• InjuryDec 7, 2020Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT PATIENT WHO UNDERWENT INITIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2016 WENT TO SEE A DOCTOR FOR FOLLOW-UP ON (B)(6) 2017. AT THE DIAGNOSIS, X-RAYS SHOWED THAT THE BEARING ON ANTERIOR SIDE LOOKED INCLINED. ON (B)(6) 2020, THE SURGEON CONFIRMED THAT THE BEARING WAS DISLOCATED. SUBSEQUENTLY, A REVISION TO REPLACE IT WITH ANOTHER BEARING (PART NUMBER US154742, LOT#075690) WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Joint Dislocation

  MAUDE report 10957498 ↗
• InjuryNov 25, 2020Device Appears to Trigger Rejection; Patient-Device Incompatibility; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO INFECTION WAS PERFORMED ON (B)(6), 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10904846 ↗
• InjuryJul 6, 2020Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED BY CLINICAL STUDY GROUP THAT PATIENT (B)(6) UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INCREASE IN LEFT KNEE SWELLING. BETAMETHASONE INJECTION WAS ADMINISTERED TO THE LEFT KNEE ON (B)(6) 2020 TO TREATMENT THE SWELLING.

  Patient problems: Edema; Swelling

  MAUDE report 10233117 ↗
• MalfunctionMar 17, 2020Problem with Sterilization; Manufacturing, Packaging or Shipping Problem; Problem with Sterilization; Manufacturing, Packaging or Shipping Problem

  DURING SURGERY, IT WAS REPORTED THAT A BLACK FOREIGN SUBSTANCE WAS FOUND ON STERILE POUCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9841362 ↗

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-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
• 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-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-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-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-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-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-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-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-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-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

…and 7 more.