BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE STEM 10MM

    MDR report key: 1983587 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01433
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
    Product Code
    KWS
    PMA / PMN Number
    K992065
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SHOULDER PAIN. IT WAS REPORTED THAT THE PATIENT HAD A MUSCULOSKELETAL PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE STEM 10MM 87KWS; 87HSD KWS JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. NA D10081895

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention