BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT

    MDR report key: 108535 · Received July 29, 1997

    Report

    Report Number
    1219655-1997-00109
    Event Type
    Injury
    Date Received
    July 29, 1997
    Report Date
    July 29, 1997
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONALS, INC.
    Product Code
    KWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PROSTHESIS BEGAN TO BREAK UP AND REVISION SURGERY WAS NECESSARY TO CORRECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT Implant PROSTHETIC ELBOW KWJ JOHNSON AND JOHNSON PROFESSIONALS, INC. NA 113LL

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention TRIAXIA ELBOW SYSTEM ULNA COMPONENT CAT# 87-2000,| LOT# B354.