BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 + 6MM

    MDR report key: 1822688 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-05729
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    PATIENT WAS REVISED TO ADDRESS SIGNIFICANT OSTEOLYSIS, POLY WEAR OF THE HUMERAL CUP, AND LOOSENING OF THE METAGLENE. IT WAS REPORTED THAT THE PATIENT HAD FALLEN, WHICH HELPED LEAD TO THE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38 + 6MM 87HSD; 87KWS HSD DEPUY FRANCE S.A. NA 2348252

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention