Oxford Partial Knee SystemRecalls & reported problems across all models
Biomet Uk Ltd · 92 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 842
- Deaths reported
- 2
- Injuries reported
- 769
- Recalls
- 1
We found 92 models of Oxford Partial Knee System by Biomet Uk Ltd in the FDA's device registry (GUDID). Together they are named in 842 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2019 and Sep 28, 2026 — classified as 2 deaths, 769 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (93 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Reports received per month, all models
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.
- Apr 17, 2020Class IITerminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2148-2020 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Oxford Partial Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem363
- Device Dislodged or Dislocated93
- Fracture90
- Insufficient Device Problem Information83
- Loosening of Implant Not Related to Bone-Ingrowth67
- Patient Device Interaction Problem65
- Material Integrity Problem30
- Naturally Worn20
Patient problems
- Pain258
- Insufficient Information204
- Failure of Implant132
- Joint Dislocation85
- No Clinical Signs, Symptoms or Conditions78
- No Information58
- Loss of Range of Motion29
- Swelling/ Edema27
Oxford Partial Knee System models
92 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Oxford Partial Knee System 159575Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 recall32 reports
- Oxford Partial Knee System 161468Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 death69 reports
- Oxford Partial Knee System 161469Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing65 reports
- OXFORD PARTIAL KNEE SYSTEM 154336PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Oxford Partial Knee System 154722Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing35 reports
- Oxford Partial Knee System 159547Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing33 reports
- Oxford® Partial Knee System 32-422097Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing32 reports
- Oxford Partial Knee System 154723Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 death32 reports
- Oxford Partial Knee System 161470Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing26 reports
- Oxford Partial Knee System 159540Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing25 reports
- Oxford Partial Knee System 154721Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing23 reports
- Oxford Partial Knee System 159548Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing23 reports
- Oxford Partial Knee System 159568Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing22 reports
- Oxford Partial Knee System 159576Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing22 reports
- Oxford Partial Knee System 154720Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing18 reports
- Oxford Partial Knee System 159577Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing18 reports
- Oxford® Partial Knee System 154718Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing17 reports
- Oxford Partial Knee System 159582Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing17 reports
- Oxford Partial Knee System 159569Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing16 reports
- Oxford Partial Knee System 154725Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing15 reports
- Oxford Partial Knee System 159541Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing15 reports
- Oxford Partial Knee System 159549Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing14 reports
- Oxford Partial Knee System 159554Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing14 reports
- Oxford Partial Knee System 154724Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing13 reports
- Oxford Partial Knee System 159542Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing12 reports
- Oxford Partial Knee System 159555Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing12 reports
- Oxford Partial Knee System 159570Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing12 reports
- Oxford Partial Knee System 159578Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing12 reports
- Oxford Partial Knee System 159583Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing12 reports
- Oxford Partial Knee System 154719Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing11 reports
- Oxford Partial Knee System 32-422703Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing9 reports
- Oxford® Partial Knee System 166574Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing7 reports
- Oxford® Partial Knee System 166575Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing7 reports
- Oxford Partial Knee System 159531Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing7 reports
- Oxford Partial Knee System 159532Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing7 reports
- Oxford Partial Knee System 159550Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing7 reports
- Oxford Partial Knee System 154726Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing6 reports
- Oxford Partial Knee System 161471Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing6 reports
- Oxford® Partial Knee System 161474Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing6 reports
- Oxford Partial Knee System 159790Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing5 reports
- Oxford Partial Knee System 160791Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing5 reports
- Oxford Partial Knee System 154775Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing5 reports
- Oxford® Partial Knee System 166572Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing4 reports
- Oxford® Partial Knee System 166577Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing4 reports
- Oxford Partial Knee System 154727Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing4 reports
- Oxford Partial Knee System 154776Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing4 reports
- Oxford® Partial Knee System 166578Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing3 reports
- Oxford Partial Knee System 154600Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- Oxford Partial Knee System 32-422698Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- Oxford Partial Knee System 154601Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- Oxford Partial Knee System 159558Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- Oxford Partial Knee System 159579Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- Oxford Partial Knee System 159584Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- Oxford® Partial Knee System 166573Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing2 reports
- Oxford® Partial Knee System 166576Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing2 reports
- Oxford® Partial Knee System 166579Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing2 reports
- Oxford® Partial Knee System 166845Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing2 reports
- Oxford® Partial Knee System 166846Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing2 reports
- Oxford Partial Knee System 159792Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159793Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 160790Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 32-422704Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 32-422708Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 154602Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 154635Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 161467Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 32-420378Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 32-420382Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159543Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159544Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159556Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159571Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159580Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159585Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 159590Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- Oxford Partial Knee System 160792Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 32-422709Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 32-422710Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 154605Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 154610Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 154620Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 154629Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 154636Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford® Partial Knee System 161473Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing1 report
- Oxford Partial Knee System 159535Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159552Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159557Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159561Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159562Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159573Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159581Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- Oxford Partial Knee System 159589Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
Recent Oxford Partial Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Implant subsidence
Patient problems: Pain
MAUDE report 50914890 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced persistent pain following implantation and expressed concern that the implanted partial device and associated instruments were subject to a recall.Attempts have been made, and no further information has been provided.
Patient problems: Pain
MAUDE report 50865538 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced persistent pain following implantation and expressed concern that the implanted partial device and associated instruments were subject to a recall.Attempts have been made, and no further information has been provided.
Patient problems: Pain
MAUDE report 50865530 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced persistent pain following implantation and expressed concern that the implanted partial device and associated instruments were subject to a recall.Attempts have been made, and no further information has been provided.
Patient problems: Pain
MAUDE report 50865524 ↗InjurySep 10, 2026Noise, Audible
It was reported that the patient reports experienced a popping sound in the knee during flexion and extension. A revision surgery was performed to replace the bearing implant.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Patient problems: Crepitus
MAUDE report 50713523 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent an initial left knee arthroplasty. Subsequently, approximately two months post-implantation, the patient underwent a revision surgery due to a tibial periprosthetic fracture.Due diligence is in progress for this complaint; no additional information or product has been received at the time of this report.
Patient problems: Periprosthetic fracture
MAUDE report 50406275 ↗InjuryJun 23, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO A TOTAL LEFT KNEE DUE TO SECOND DISLOCATION OF POLY SINCE INITIAL IMPLANTATION. REVISION SURGERY DUE TO FIRST DISLOCATION OF THE BEARING WAS REPORTED UNDER 3002806535-2022-00437. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25593620 ↗InjuryJun 8, 2026Fracture; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FIVE YEARS AND SEVEN MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BEARING IMPLANT AFTER IT FRACTURED FOLLOWING SEVERE DELAMINATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25427207 ↗MalfunctionJun 1, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT, UPON OPENING THE BLISTER PACKAGING OF THE TIBIAL IMPLANT, A HAIR WAS FOUND INSIDE THE PACKAGE. A BACKUP IMPLANT WAS SUBSEQUENTLY USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED CONSEQUENCES OR ADVERSE IMPACTS TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349036 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT CONVERSION OF A UNICOMPARTMENTAL KNEE ARTHROPLASTY TO A LEFT TOTAL KNEE ARTHROPLASTY EIGHT AND A HALF YEARS POST IMPLANTATION DUE TO LATERAL DISEASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25298457 ↗MalfunctionMay 22, 2026Fracture
IT WAS REPORTED THAT AN INSTRUMENT BROKE AT THE TIP WHILE IN USE. THE BROKEN PORTION DID NOT CONTACT THE PATIENT, AND NO FRAGMENTS REMAINED. THE INSTRUMENT HAD BEEN USED APPROXIMATELY 40 TIMES, AND THE PROCEDURE EXPERIENCED A BRIEF DELAY OF APPROXIMATELY FIVE MINUTES WHILE THE INSTRUMENT WAS REPLACED. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25253368 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY FOLLOWING A PERIPROSTHETIC FRACTURE OF THE TIBIA, DURING WHICH ALL PROSTHETIC COMPONENTS WERE REMOVED. APPROXIMATELY 25 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 25091797 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY FOLLOWING A PERIPROSTHETIC FRACTURE OF THE TIBIA, DURING WHICH ALL PROSTHETIC COMPONENTS WERE REMOVED. APPROXIMATELY 25 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 25091787 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY FOLLOWING A PERIPROSTHETIC FRACTURE OF THE TIBIA, DURING WHICH ALL PROSTHETIC COMPONENTS WERE REMOVED. APPROXIMATELY 25 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 25091781 ↗MalfunctionFeb 27, 2026Packaging Problem
IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGE, THE SURGEON OBSERVED THAT THE INNER STERILE PACKAGING WAS NOT VACUUM SEALED. FIVE PACKAGES IN TOTAL FROM DIFFERENT BATCHES WERE OPENED AND REPORTEDLY EXHIBITED THE SAME CONDITION. IT WAS UNCLEAR WHETHER THE ISSUE WAS DUE TO A PACKAGING DAMAGE OR A POTENTIAL DESIGN CHANGE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES OR PATIENT IMPACT, AND THE PROCEDURE WAS COMPLETED USING BACK-UP IMPLANTS. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468434 ↗
Other Biomet Uk Ltd products
All Biomet Uk Ltd devices →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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