BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE STEM 14 MM

    MDR report key: 2033988 · Received March 17, 2011

    Report

    Report Number
    1818910-2011-04229
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K992065
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 CATASTROPHIC FAILURE OF GLENOID, POSSIBLE INFECTION, OSTEOLYSIS, POLY WEAR OF TH GLENOID, AND LOOSENING OF THE HUMERAL STEM WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE STEM 14 MM 87KWS; 87HSD KWS DEPUY ORTHOPAEDICS, INC. NA WP8AD1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention