BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2983603 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-04033
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 13, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. NOT RETURNED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT IS A SURGICAL RECIPIENT OF A DEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT SYSTEM. CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BODY. PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT AND INFLAMMATION IN THE AREA OF THE IMPLANT. PATIENT ALSO EXPERIENCED DISLOCATION, DISARTICULATION, AND/OR A SLIPPING FEELING IN THE HIP JOINT AND A SENSATION THAT IMPLANT COULD NOT SUPPORT THEIR WEIGHT. PATIENT IS PART OF A MULTI-PLAINTIFF LITIGATION. IT IS UNCLEAR WHICH SYMPTOMS ARE SPECIFIC TO THE PATIENT AND WHETHER OR NOT PATIENT HAS BEEN REVISED. UPDATE: (B)(4) 2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85660 ARTICULEZE M HEAD 36MM +8.5 FEMORAL HEAD JDI DEPUY INTERNATIONAL 2077266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other