Oxford Partial Knee System 161470Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05019279438259), received between Jun 20, 2019 and Jul 15, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TO KNEE REVISION SURGERY DUE TO UNKNOWN REASON. APPROXIMATELY 8 YEARS, 6 MONTHS, AND 9 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 22505358 ↗
• InjuryDec 10, 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 20892363 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT RIGHT KNEE REVISION APPROXIMATELY 8 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20777770 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED PATIENT UNDERWENT RIGHT KNEE REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION DUE TO LATERAL PROGRESSION. THIS IS A VOID REPORT; THIS EVENT IS NO LONGER REPORTABLE DUE TO DISEASE PROGRESSION.

  Patient problems: Arthritis; Insufficient Information

  MAUDE report 20650334 ↗
• InjuryJun 4, 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: Pain

  MAUDE report 19457929 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19228117 ↗
• InjuryApr 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF UNICOMPARTMENTAL COMPONENTS THREE AND A HALF YEARS POST IMPLANTATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19078049 ↗
• InjuryApr 8, 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: Joint Laxity; Pain

  MAUDE report 19057980 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 17995082 ↗
• InjuryOct 12, 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 17918438 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Arthritis; Insufficient Information

  MAUDE report 17583622 ↗
• InjuryJul 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PARTIAL KNEE ARTHROPLASTY AND APPROXIMATELY 5 YEARS LATER A REVISION SURGERY WAS PERFORMED 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 17253689 ↗
• InjuryMar 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AFTER NEARLY 10-YEAR POST-IMPLANTATION OF RIGHT KNEE IMPLANT 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 16583374 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY AND APPROXIMATELY 5 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO PAIN. CONTRIBUTING FACTOR WAS DISEASE PROGRESSION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 16484013 ↗
• InjuryDec 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY AND APPROXIMATELY 8 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Metal Related Pathology

  MAUDE report 15930625 ↗
• InjuryFeb 9, 2022Adverse 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) 2021. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASONS WAS PERFORMED ON (B)(6) 2022. PATIENT OUTCOME: REVISION. NO DELAY.

  Patient problems: Failure of Implant

  MAUDE report 13497093 ↗
• InjuryNov 15, 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 PAIN AND LATERAL WEAR WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12810997 ↗
• InjurySep 1, 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), 2016. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO PAIN WAS PERFORMED ON (B)(6), 2021. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 12406913 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ON CLINICAL STUDY PRESENTED FOR 10 MONTH RECHECK POST OP LEFT MEDIAL UCKR DONE ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT TRIPPED AND FELL ONTO HIS LEFT KNEE. REPORTED MINIMAL SYMPTOMS WHEN UP WALKING, BUT REPORTS PAIN AND DECREASED FLEXION WITH ACTIVITIES SUCH AS STAIRS, KNEELING, AND RISING FROM A CHAIR. SUBSEQUENTLY, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA (MUA) ON (B)(6) 2021 WHICH RESOLVED THE SYMPTOMS.

  Patient problems: Pain

  MAUDE report 12265725 ↗
• InjuryJun 17, 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) 2017. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016108 ↗
• InjuryMay 14, 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) 2017. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021

  Patient problems: Insufficient Information

  MAUDE report 11824322 ↗
• InjuryJan 26, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON AN (B)(6) 2020. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO IMPLANT FRACTURE WAS PERFORMED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11228540 ↗
• InjuryNov 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE REPLACEMENT PROCEDURE. 5 YEARS POST-OP, THE PATIENT BEGAN EXPERIENCING PAIN, REDNESS AND EDEMA IN HIS LEFT LEG TOGETHER WITH A FEVER (CELLULITIS). THESE SYMPTOMS OCCURRED 2-3 DAYS AFTER A RETURN FLIGHT FROM ITALY. THE PATIENT WAS ADMITTED TO HOSPITAL FOR 7 DAYS. TREATMENT INCLUDED IV ANTIBIOTICS, THE PATIENT ALSO NEEDED TO WEAR COMPRESSION STOCKINGS AND KEEP LEG ELEVATED.

  Patient problems: Edema; Fever; Pain

  MAUDE report 9304122 ↗
• InjuryJul 9, 2019Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION DUE TO LATERAL WEAR.

  Patient problems: No Information

  MAUDE report 8770627 ↗
• InjuryJul 4, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT RIGHT KNEE ATHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT ARTHROTOMY AND DEBRIDEMENT DUE TO EXPERIENCING PAIN, POPPING/CLICKING AND CATCHING OF RIGHT KNEE. SURGEON FURTHER REPORTED ENTRAPPED AND INFLAMED SYNOVIUM TISSUE, AS WELL AS A SMALL AMOUNT OF HO BONE WAS EXCISED. FOLLOW-UP APPOINTMENT POST PROCEDURE REPORTED SYMPTOMS WERE NO LONGER PRESENT.

  Patient problems: Inflammation; Pain

  MAUDE report 8762251 ↗

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

…and 7 more.