BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ASR HIP

    MDR report key: 1892329 · Received November 2, 2010

    Report

    Report Number
    1818910-2010-08242
    Event Type
    Injury
    Date Received
    November 2, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED FROM PERSISTENT DISCOMFORT AND PAIN IN HER HIP. IT IS FURTHER ALLEGED THAT SHE IS SCHEDULED FOR REVISION SURGERY DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY ASR HIP TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention