BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMPLANT SZ 55

    MDR report key: 1243070 · Received November 21, 2008

    Report

    Report Number
    1818910-2008-05187
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 24, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWY
    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 THE 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

    PT REVISED TO ADDRESS PERSISTENT PAIN. INTRAOPERATIVELY IT WAS NOTED THAT THE CUP HAD 'SPUN' AND IMPINGED FEMORAL NECK. EXTENSIVE METALLOSIS WAS ALSO NOTED AT REVISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMPLANT SZ 55 TOTAL HIP REPLACEMENT KWY DEPUY INTERNATIONAL, LTD NA 2356108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention