Oxford Partial Knee System 159531Recalls & reported problems
Biomet Uk Ltd · Class 3 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05019279783137), received between Sep 30, 2020 and Aug 21, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Failure of Implant4
- Pain2
- Insufficient Information1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2024Loosening 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 20023006 ↗InjuryMar 18, 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 18919853 ↗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 IMPLANT. 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 18362180 ↗InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION 27 MONTHS POST-IMPLANTATION DUE TO PAIN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Pain
MAUDE report 15402109 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A REVISION OF LEFT KNEE DUE TO UNKNOWN REASONS, APPROXIMATELY TWO (2) YEARS POST-OP. 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 15182471 ↗InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2017. SUBSEQUENTLY, WAS REVISED DUE TO PAIN AND HEMARTHROSIS ON (B)(6) 2021.
Patient problems: Pain
MAUDE report 12098327 ↗InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO LATERAL WEAR.
Patient problems: No Information
MAUDE report 10604742 ↗
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-1159-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1165-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
- Z-1158-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1164-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1153-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1168-2017 · Jan 5, 2016 · TerminatedOxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1155-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1157-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1163-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1160-2017 · Jan 5, 2016 · TerminatedOxford 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 · TerminatedOxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1161-2017 · Jan 5, 2016 · TerminatedOxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1170-2017 · Jan 5, 2016 · TerminatedOxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1154-2017 · Jan 5, 2016 · TerminatedOxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Z-1169-2017 · Jan 5, 2016 · TerminatedOxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
…and 7 more.
Other Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing devices
- Oxford Partial Knee System 159575Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 recall32 reports
- Oxford Partial Knee System 161468Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 death69 reports
- Oxford Partial Knee System 161469Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing65 reports
- Oxford Partial Knee System 154722Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing35 reports
- Oxford Partial Knee System 159547Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing33 reports
- Oxford® Partial Knee System 32-422097Biomet Uk Ltd · Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing32 reports
- Oxford Partial Knee System 154723Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 death32 reports
- Oxford Partial Knee System 161470Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing26 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.