BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE TOTAL FEMORAL HEAD W/BFH

    MDR report key: 1012617 · Received March 10, 2008

    Report

    Report Number
    1043534-2008-00030
    Event Type
    Injury
    Date Received
    March 10, 2008
    Report Date
    February 8, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 1043534-2008-00029. THIS EVEN OCCURRED IN A FOREIGN COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, BILATERAL PT HAS ONE FAILED SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE TOTAL FEMORAL HEAD W/BFH KWA WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R