BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND STAND PE CUP D38 +6MM

    MDR report key: 1140679 · Received August 27, 2008

    Report

    Report Number
    1818910-2008-03489
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    PMA / PMN Number
    K081620
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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

    THE CUPS WOULD NOT SEAT CORRECTLY, CAUSING A 30 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38 +6MM 87KWS & 87HSD KWS DEPUY FRANCE S.A. NA 2348251

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR