BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE TOTAL HEAD W/BFH

    MDR report key: 1033301 · Received April 22, 2008

    Report

    Report Number
    1043534-2008-00072
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    January 14, 2008
    Report Date
    April 1, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. PRODUCT NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO HAVE PRODUCT RETURNED. TRENDS WILL BE EVALUATED. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00073. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    NORMAL ACTIVITY LEVEL. ALLEGEDLY 3 MOS AFTER IMPLANTATION A SEIZING WITH NOISE APPEARED. THE JOINT BECAME REALLY HARD TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE TOTAL HEAD W/BFH KWA WRIGHT MEDICAL TECHNOLOGY, INC. 106379492

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R