BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 1052793 · Received May 20, 2008

    Report

    Report Number
    1043534-2008-00098
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 14, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00097, 00099. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY STEM LOOSENING, DUE TO UNDERSIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR MODULAR FEMORAL NECK LWJ WRIGHT MEDICAL TECHNOLOGY, INC. U0671666

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R