BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 1082148 · Received July 24, 2008

    Report

    Report Number
    1043534-2008-00166
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 15, 2008
    Report Date
    July 3, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, MODULAR NECK RUPTURE OCCURRED AFTER SLIPPAGE AND ROTATION OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK LWJ WRIGHT MEDICAL TECHNOLOGY, INC. W06334966

    Patients

    Seq Age Sex Outcome Treatment
    1