BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3122612 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00277
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K111061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT'S SHOULDER HAD INFECTION AND WAS UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214821 RSP SHOULDER RSP MONOBLOCK +8MM SPACER KWS ENCORE MEDICAL, L.P. 142G1027

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention (B)(4), LOT 862C1225| (B)(4), LOT 922F1012