BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2983489 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-04032
    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. DEVICE 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 PATIENTS 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)(6) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. BECAUSE OF THE ALLEGATIONS OF DISLOCATION THE HEAD AND LINER ARE BEING REPORTED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86369 ARTICULEZE M HEAD 36MM +5 FEMORAL HEAD JDI DEPUY INTERNATIONAL 1918799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other