Oxford Partial Knee System 161468Recalls & reported problems
Biomet Uk Ltd · Twin Peg Femoral · Class 3 · Implant
All models of Oxford Partial Knee System (92)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Oxford Partial Knee System Twin Peg Femoral implant is a metal-on-plastic knee replacement that replaces only part of the knee joint. The 69 reports mostly describe knee pain, implants loosening and wearing out over time, and a few cases where the implant slipped out of place, with several patients needing revision surgery. One death and 68 injuries were reported. No recalls name this device, and reports in the last 12 months (2) are fewer than the 8 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 69
- Deaths reported
- 1
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05019279438228), received between Jun 5, 2019 and Jan 2, 2026 — classified as 1 death, 68 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem40
- Loosening of Implant Not Related to Bone-Ingrowth11
- Patient Device Interaction Problem8
- Insufficient Device Problem Information6
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated3
- Degraded1
- Malposition of Device1
Patient problems
- Insufficient Information22
- Pain20
- Failure of Implant12
- No Information7
- Ambulation or Postural Difficulties3
- Joint Dislocation3
- Loss of Range of Motion3
- Aseptic loosening2
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23941868 ↗InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 23629891 ↗InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY ONE YEAR AND TEN MONTHS POST IMPLANTATION, THEY UNDERWENT A 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: Aseptic loosening; Bone Fracture(s); Insufficient Information; Pain
MAUDE report 22381629 ↗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 21729187 ↗InjuryFeb 18, 2025Adverse 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 21400424 ↗InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
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 21392681 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 21250894 ↗InjuryJan 24, 2025Adverse 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 AN UNKNOWN REASON. APPROXIMATELY 7 YEARS AND 10 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 21228000 ↗InjuryNov 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 20707597 ↗InjuryNov 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: Pain
MAUDE report 20707534 ↗InjurySep 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: Pain
MAUDE report 20168446 ↗InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 20088508 ↗InjuryJul 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING. DURING THE REVISION POSTEROMEDIAL COLLAPSE WAS NOTED. ALL IMPLANTS WERE REMOVED WITHOUT COMPLICATIONS. APPROXIMATELY 7 YEARS AND 5 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 19750416 ↗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 19592758 ↗InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY AND DEVELOPED PNEUMONIA AND HYPOTENSION WITHIN A WEEK OF THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Low Blood Pressure/ Hypotension; Pneumonia
MAUDE report 19357485 ↗InjuryApr 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PARTIAL RIGHT KNEE ARTHROPLASTY. APPROXIMATELY TEN YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 19104588 ↗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 19069188 ↗InjuryMar 25, 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 18969556 ↗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 18920115 ↗InjuryJan 2, 2024Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY APPROXIMATELY A YEAR AND A HALF AGO. SUBSEQUENTLY, THE PATIENT HAD A SLOW PROGRESSIVE RECOVERY AND NEVER EXPERIENCED PAIN RELIEF. THE REPORTED PAIN WAS INITIALLY IN THE POSTERIOR LATERAL KNEE ALONG WITH SWELLING, STIFFNESS, AND LIMITED FLEXION AND RADIOGRAPHIC IMAGING POINTED TOWARDS LATERAL DEGENERATIVE CHANGES. THE PATIENT WAS NOTED TO HAVE HYPERSENSITIVITY AND WAS DIAGNOSED WITH CHRONIC KNEE PAIN AND FIBROMYALGIA. RADIOGRAPHIC IMAGING TAKEN POST OPERATIVELY DISPLAYED A ROUND AREA OF PERIPROSTHETIC LUCENCY WITH THIN SCLEROTIC MARGINS AT THE CEMENT BONE INTERFACE OF THE POSTERIOR FEMORAL POST, A LUCENCY BENEATH THE CEMENT BONE INTERFACE POSTERIORLY ON THE TIBIAL COMPONENT, AND THE FEMORAL COMPONENT WAS NOTED TO BE SOMEWHAT POSTERIOR WITH A SLIGHT LATERAL PATELLAR TILT. THE SURGEON HAS DISCUSSED A POSSIBLE REVISION AND IS SEEKING SPECIALTY CARE FOR AN APPROACH TO PREVENT COMPLEX REGIONAL PAIN SYNDROME FROM DEVELOPING IF ANOTHER SURGERY IS REQUIRED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Loss of Range of Motion; Pain; Radiolucent Lines; Swelling/ Edema
MAUDE report 18424305 ↗InjuryDec 27, 2023Loosening 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 18396913 ↗InjuryDec 20, 2023Loosening 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 18362204 ↗InjuryDec 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THE EVENT IS A DUPLICATE OF (B)(4). THIS EVENT HAS BEEN REPORTED IN (B)(4). GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.
Patient problems: Failure of Implant
MAUDE report 18354106 ↗InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNI KNEE ARTHROPLASTY AND APPROXIMATELY 7 MONTHS LATER A REVISION SURGERY WAS PERFORMED DUE TO THE FAILED IMPLANT ON TIBIAL SIDE. THERE WAS A VISIBLE CYST ABOUT THE SIZE OF A MARBLE TOWARD TO POSTERIOR ASPECT OF THE TIBIA THAT WAS MOSTLY CONTAINED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Cyst(s); Failure of Implant
MAUDE report 18343139 ↗InjuryNov 20, 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: Fall; Osteolysis
MAUDE report 18168288 ↗
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 · TerminatedOxford 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 · TerminatedOxford 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 · TerminatedOxford 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 · TerminatedOxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- 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-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
- 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-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-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-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-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-1171-2017 · Jan 5, 2016 · TerminatedOxford 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 · TerminatedOxford Partial Knee System Femoral Slap Hammer 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 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
- Oxford Partial Knee System 159540Biomet Uk Ltd · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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