Oxford® Partial Knee System 154361Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Oxford Partial Knee System (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05019279515554), received between Dec 17, 2020 and Mar 2, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Degraded” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K133940); 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
Device problems
- Degraded1
- Material Integrity Problem1
- Naturally Worn1
Patient problems
- Muscle/Tendon Damage1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS AN INSUFFICIENT MEDIAL COLLATERAL LIGAMENT (MCL) APPROXIMATELY SEVEN (7) MONTHS POST-OPERATIVELY. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE LATERAL BEARING WAS SIGNIFICANTLY WORN. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Muscle/Tendon Damage
MAUDE report 11398770 ↗InjuryDec 17, 2020Degraded; Material Integrity Problem; Degraded; Material Integrity Problem
THE PATIENT WAS REVISED DUE TO INSUFFICIENT MEDIAL COLLATERAL LIGAMENT (MCL), BUT WHEN THE SURGEON SAW THE IMPLANT HE WAS CONCERNED ABOUT HOW MUCH WEAR OCCURRED IN JUST 6 MONTHS TO THE OXFORD FIXED LATERAL BEARING.
Patient problems: No Information
MAUDE report 11026920 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133940. One submission often covers many models, so check the product and lot details in each record.
- Z-1018-2023 · Dec 15, 2022 · Open, ClassifiedOxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 15434
- Z-0624-2021 · Nov 25, 2020 · TerminatedOxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
- Z-2148-2020 · Apr 17, 2020 · TerminatedKnee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cement
- Z-0956-2017 · Dec 6, 2016 · TerminatedOxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flu
Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 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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