Oxford Partial Knee SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Oxford Partial Knee System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 2
We found 10 models of Oxford Partial Knee System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2020 and May 18, 2023 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Degraded” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Oxford Partial Knee System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 15, 2022Class IIOpen, Classified
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Z-1018-2023 · Root cause: Package design/selection · Recall details · FDA record ↗
- Apr 17, 2020Class IITerminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2148-2020 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
Most reported Oxford Partial Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
- Material Integrity Problem1
- Naturally Worn1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Adhesion(s)1
- Loss of Range of Motion1
- Muscle/Tendon Damage1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Oxford Partial Knee System models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Oxford® Partial Knee System 154370PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- Oxford® Partial Knee System 154335PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154339PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154341PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154355PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154375PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154376PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154377PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford® Partial Knee System 154361PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Oxford® Partial Knee System 154333PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent Oxford Partial Knee System adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE NURSE OPENED THE PACKAGING AND NOTICED A HOLE IN THE FIRST PLASTIC LAYER. THE IMPLANT COULD NOT BE USED AS IT MAY HAVE NOT BEEN STERILE. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16952360 ↗InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY TWO (2) MONTHS FOLLOWING KNEE ARTHROPLASTY. FOLLOWING THE MANIPULATION, THE PATIENT'S RANGE OF MOTION IMPROVED AND THE PATIENT WAS ABLE TO RESUME REGULAR ACTIVITIES. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. MANIPULATION OPERATIVE NOTES NOTED THAT FLEXION MANIPULATION WAS PERFORMED AND CAREFUL BREAKING OF SCAR TISSUE ADHESIONS WAS AUDIBLE.
Patient problems: Adhesion(s); Loss of Range of Motion
MAUDE report 13424838 ↗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 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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