BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND STAND PE CUP D38 +9MM

    MDR report key: 1040961 · Received May 7, 2008

    Report

    Report Number
    1818910-2008-01385
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    FINAL POLY CUP WOULD NOT SEAT DURING PROCEDURE. SURGEON WAS ABLE TO LEVER PRODUCT OUT WITH VERY LITTLE PRESSURE, EVEN WHEN IT WASN'T ROTATING. SURGEON TIRED TWO DIFFERENT POLY CUPS OF SAME LOT, WITH THE SAME PROBLEM. FINALLY, A THIRD POLY CUP OF A DIFFERENT LOT WAS IMPLANTED. THIS PROBLEM RESULTED IN A 20-30- MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38 +9MM 87HSD HSD DEPUY FRANCE S.A. NA 2430586

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR