BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 4 PMA

    MDR report key: 24826447 · Received April 9, 2026

    Report

    Report Number
    3002806535-2026-00144
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786152
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: ITEM NAME# OXF UNI CMNTLS TIB SZ A RM; ITEM NUMBER# 166846; LOT NUMBER# 66935822. ITEM NAME# OXF TWIN PEG CMNTLS FMRL SM; ITEM NUMBER# 161473; LOT NUMBER# 67115574. 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 THAT THE PATIENT UNDERWENT TO KNEE REVISION SURGERY DUE TO UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543457 OXF ANAT BRG RT SM SIZE 4 PMA PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED,METAL/POLYMER NRA BIOMET UK LTD. 67121232 05019279786152

    Patients

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