BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 4 PMA

    MDR report key: 24333031 · Received February 13, 2026

    Report

    Report Number
    3002806535-2026-00084
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 13, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785940
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM NAME# OXF TWIN PEG CMNTLS FMRL MD; ITEM NUMBER# 161474; LOT NUMBER # 66872822. ITEM NAME# OXF UNI CMNTLS TIB SZ D LM; ITEM NUMBER# 166576; LOT NUMBER # 66935835. ITEM NAME# CMTLS OXF UNI FM/ CMTLS TB/ UNI; ITEM NUMBER# 98-0002-005-45; LOT NUMBER # UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A KNEE BEARING EXCHANGE APPROXIMATELY 6 MONTHS POST-IMPLANTATION DUE TO ANTERIOR BEARING DISLOCATION. X-RAYS REPORTEDLY APPEARED ACCEPTABLE WITHOUT OBVIOUS IMPINGEMENT. INTRA-OPERATIVELY, GAP BALANCE WAS ASSESSED AND A 4 MM BEARING WAS FOUND TO BE GROSSLY LOOSE; THE POLYETHYLENE THICKNESS WAS UPSIZED WITHOUT OVERSTUFFING. THE MEDIAL COLLATERAL LIGAMENT WAS DEEMED SUFFICIENT, AND AN 8 MM POLYETHYLENE BEARING WAS IMPLANTED TO ACHIEVE A BALANCED KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397432 OXF ANAT BRG LT MD SIZE 4 PMA PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED NRA BIOMET UK LTD. 66058720 05019279785940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE.