BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMPLANT SZ 55

    MDR report key: 1240003 · Received November 19, 2008

    Report

    Report Number
    1818910-2008-05189
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    April 22, 2008
    Report Date
    October 24, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER NOT PROVIDED BECAUSE THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. 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

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMPLANT SZ 55 TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD. NA 2286958

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention