BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTED HUM EPIPHYSIS 36.1

    MDR report key: 1053589 · Received May 22, 2008

    Report

    Report Number
    1818910-2008-01690
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 23, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    PMA / PMN Number
    K021478
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    REVISION DUE TO COMPLETE UNSCREWING OF HUMERAL LENGTHENER, IF FOUND DISASSEMBLED FROM THE OTHER COMPONENT. THE PT HAD PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMENTED HUM EPIPHYSIS 36.1 87KWS KWS DEPUY FRANCE S.A. NA 2468270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention