BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 1954470 · Received January 5, 2011

    Report

    Report Number
    1818910-2011-00003
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    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

    LITIGATION PAPERS ALLEGE THE PATIENT BEGAN EXPERIENCING UNSTEADINESS, DIFFICULTY WALKING, AND "GRINDING" AND "KNOCKING" IN HER RIGHT HIP. ADDITIONALLY, IT IS ALLEGED SHE WILL NEED TO UNDERGO TESTING AND MEDICAL MONITORING INCLUDING RADIOGRAPHIC EVALUATION; BLOOD TESTING, AND AN MRI. PATIENT WAS REVISED ON (B)(6) 2010 TO ADDRESS IMPLANT GRINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2163404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention