BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3813401 · Received May 15, 2014

    Report

    Report Number
    1818910-2014-18844
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    January 29, 2013
    Report Date
    May 1, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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

    FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANT REVISION. REPORTED PAIN AND SUBLUXING IN (B)(6) 2011. REVISION FOUND FIBROCOLLAGENOUS TISSUE SHOWING FEATURES OF METALLOSIS AND MILD ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292034 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. REG. # 8010379 2541568

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other| R