BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2844327 · Received November 26, 2012

    Report

    Report Number
    1818910-2012-28057
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING REJECTED BECAUSE IT HAS BEEN IDENTIFIED AS BEING A DUPLICATE OF ANOTHER REPORT, 1818910-2012-28122.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BI-LATERALLY TO ADDRESS PAIN, CLICKING AND POPPING, AND ELEVATED COBALT BLOOD LEVELS. DOI (B)(4) 2005 - DOR (B)(4) 2012 BOTH HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +1.5 FEMORAL HEAD JDI DEPUY INTERNATIONAL 1867129

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention