BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3830323 · Received May 23, 2014

    Report

    Report Number
    3010536692-2014-00866
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    June 20, 2012
    Report Date
    May 7, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BROKEN MODULAR NECK (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307731 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. S09112687

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention