Oxford® Partial Knee System 154718Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05019279388844), received between Jun 26, 2019 and Mar 31, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 21729190 ↗
• InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 21398941 ↗
• 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 19069186 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN 11 MONTHS POST SURGERY WHICH WAS RESOLVED BY OSTEOPLASTY SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 18073585 ↗
• InjurySep 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO A TOTAL KNEE APPROXIMATELY ONE YEAR AND FIVE MONTHS POST INITIAL LEFT PARTIAL KNEE REPLACEMENT, DUE TO TIBIAL BASEPLATE LOOSENING. POOR BONE QUALITY WAS NOTED DURING THE SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Osteopenia/ Osteoporosis; Pain; Swelling/ Edema

  MAUDE report 17842324 ↗
• InjurySep 19, 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: Ambulation or Postural Difficulties; Fall; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 17770954 ↗
• InjurySep 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE 3 YEARS POST-IMPLANTATION. PATIENT WAS REVISED TO PRIMARY TKA. 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 15507310 ↗
• 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 14539606 ↗
• MalfunctionOct 8, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SURGERY, IT WOULD DISCOVERED THAT THE STERILE PACKAGING WAS RIPPED ON THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597902 ↗
• 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 12559744 ↗
• InjuryMay 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON AN (B)(6) 2018. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO SUBSIDED TIBIAL COMPONENT WAS PERFORMED ON (B)(6) 2021. UNI CONVERSION TO TKA WITH SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876025 ↗
• 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 AN (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020 THE PATIENT ATTENDED THE PHYSICIANS OFFICE DUE TO STIFFNESS, POSTEROLATERAL KNEE PAIN, PAIN WITH EXTENSION, AND BUCKLING. THE SYMPTOMS WERE TREATED WITH A CORTISONE INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 11853697 ↗
• 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11840083 ↗
• 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 11228843 ↗
• 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 10957496 ↗
• 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 10233115 ↗
• InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 8734809 ↗

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

…and 7 more.