BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 1911666 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-09202
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 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
    AL, 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 IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2010 TO ADDRESS RECURRING PAIN, AS WELL AS CLICKING AND POPPING IN HER HIP. IT IS FURTHER ALLEGED THE PATIENT SUFFERED FROM UNKNOWN RASHES. INFORMATION RECEIVED FROM THE SALES REP INDICATES THAT THE PATIENT WAS REVISED ON (B)(6) 2010 TO ADDRESS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2903839

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention