BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR RADEL TRIAL NECK

    MDR report key: 2212435 · Received November 6, 2007

    Report

    Report Number
    1043534-2007-00193
    Event Type
    Injury
    Date Received
    November 6, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 30, 2007
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ADVERSE EVENT, PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR RADEL TRIAL NECK HIP INSTRUMENT LXH WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R