BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIBIAL BEARING

    MDR report key: 1192823 · Received October 10, 2008

    Report

    Report Number
    1825034-2008-00263
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    May 19, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE PROCEDURE IN 2006. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURE DUE TO THE POLYETHYLENE TIBIAL BEARING COMING OUT AND WAS SITTING WHERE HIS KNEECAP SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNI TIBIAL BEARING PROSTHESIS, KNEE COMPONENT NRA BIOMET INC. N/A 881043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S