BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE STEM 8 MM

    MDR report key: 1233638 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-05445
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K992065
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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

    PT WAS REVISED BECAUSE THE STEM WAS IMPLANTED TOO PROUD, RESULTING IN PAIN AND TIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE STEM 8 MM 87KWS KWS DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention