BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38+3MM

    MDR report key: 1013862 · Received March 14, 2008

    Report

    Report Number
    1818910-2008-00605
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    SURGEON CEMENTED IN A SIZE 1, 10 DIAMETER STEM AND IMPACTED A 38 +3 POLY, BUT POLY WOULD NOT SEAT. A NEW POLY WAS OPENED, BUT WOULD NOT SEAT. SURGEON DID NOT WANT TO GO TO A +6 POLY BECAUSE, HE FELT IT WOULD BE TOO TIGHT. A SIZE 8 STEM WAS OPENED TO TEST +3 POLY TO DETERMINE IF IT WAS THE STEM OR POLY THAT WAS BAD. THE POLY LOCKED INTO THE 8 STEM WITH NO DIFFICULTY, LEAVING THE SURGEON TO CONCLUDE THAT THE SIZE 10 STEM WHICH WAS ALREADY CEMENTED INTO THE PT WAS THE PROBLEM. THIS PROBLEM RESULTED IN A 25-MIN EXTENSION OF SURGICAL TIME. (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38+3MM 87HSD; 87KWS HSD DEPUY FRANCE S.A. NA 2345289

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention