BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA HEAD

    MDR report key: 1251275 · Received December 4, 2008

    Report

    Report Number
    1043534-2008-00341
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    December 27, 2007
    Report Date
    December 3, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    PMA / PMN Number
    P030027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/CORRECTION: THIS ITEM WAS REMOVED DURING THE REVISION OF ANOTHER PRODUCT. INVESTIGATION IS NOT COMPLETE. NO COMPLAINT WAS STATED AGAINST THIS ITEM. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, THE HEAD WAS REMOVED DURING A REVISION SURGERY. NO COMPLAINT WAS STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA HEAD MRA WRIGHT MEDICAL TECHNOLOGY, INC. NA P0251397

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R