BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2214044 · Received August 2, 2011

    Report

    Report Number
    1644408-2011-00429
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO AN INFECTED SHOULDER, THERE WERE NO ISSUES WITH THE IMPLANTS FAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER PRIMARY HUMERAL STEM KWS ENCORE MEDICAL, L.P. 54041300

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 506-03-118, LOT 54057665/53997307| 508-00-008, LOT A1000001| 508-32-104, LOT 54048928| 508-00-032, LOT 54057655| 506-03-122, LOT 54012128| 508-32-101, LOT 54033697