BEUDAMED
    FDA Adverse Event Summary report: N

    ALUMINA HEAD

    MDR report key: 1052878 · Received May 20, 2008

    Report

    Report Number
    1043534-2008-00110
    Date Received
    May 20, 2008
    Report Date
    April 28, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    PMA / PMN Number
    P030027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 EVENT OCCURRED IN A FOREIGN COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY THE PT HAS NOTICED MECHANICAL NOISES IN MOVING THE INTERESTED LEG. MULTI-FRAGMENTED FRACTURE OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA HEAD MRA WRIGHT MEDICAL TECHNOLOGY, INC. T05127119

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R