BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPIPHYSIS DISTAL FEMUR

    MDR report key: 1230241 · Received November 13, 2008

    Report

    Report Number
    1043534-2008-00322
    Event Type
    Injury
    Date Received
    November 13, 2008
    Report Date
    November 4, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRO
    PMA / PMN Number
    K021489
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THE PRODUCT WAS NOT RETURNED FOR EVAL. ADD'L INFO HAS BEEN REQUESTED. THE EVENT DEVICE CODE IS ADDRESSED IN TTHE PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETED. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, REVISED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPIPHYSIS DISTAL FEMUR KRO WRIGHT MEDICAL TECHNOLOGY, INC. NA 479686

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R