BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND MBLOC HUM EPI 1 D8 STD

    MDR report key: 1063268 · Received June 18, 2008

    Report

    Report Number
    1818910-2008-02466
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE INSERT DID NOT FIT INTO THE STEM, SOMETHING WRONG WITH THE STEM, EPIPHYSEAL PART. SURGERY DELAYED UP TO 1.5 HRS, LOT OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND MBLOC HUM EPI 1 D8 STD 87HSD HSD DEPUY FRANCE S.A. NA 2322144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA