BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2915068 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-01105
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    August 23, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN, STIFFNESS, DISCOMFORT, EXCESSIVE LEVELS OF CHROMIUM AND COBALT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECT THE PATIENTS MOBILITY AND QUALITY OF LIFE. HE ALSO EXPERIENCED CLICKING AND POPPING OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22092 ASR ACETABULAR CUPS 60 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2615388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other