BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOBAL ADVANTAGE PC STEM 12MM

    MDR report key: 1378340 · Received April 16, 2009

    Report

    Report Number
    1818910-2009-01694
    Event Type
    Other
    Date Received
    April 16, 2009
    Date of Event
    March 17, 2009
    Report Date
    March 17, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBF
    PMA / PMN Number
    K011047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    TRIALED AND BROACHED FOR A SIZE 12, HOWEVER, SIZE 12 IMPLANT TO SMALL. SURGEON CEMENTED STEM IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE PC STEM 12MM 87MBF MBF DEPUY ORTHOPAEDICS, INC. NA DD2JY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR