BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3241532 · Received July 22, 2013

    Report

    Report Number
    1043534-2013-01188
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BROKEN NECK. IT HAPPENED IN DAILY LIFE, NO SPORT. NORMAL ACTIVITY LEVEL. ORIG. SURG. IN 2009. WE HAVE NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341595 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT, CODE:LWJ LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 029784222

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention