BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2230456 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17106
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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

    PATIENT UNDERWENT THE TOTAL HIP REVISION SURGERY DUE TO PAIN AND ELEVATED CHROMIUM LEVELS IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 HIP JDI DEPUY INTERNATIONAL 2105496

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention