BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2163693 · Received June 15, 2011

    Report

    Report Number
    1644408-2011-00334
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD NO GLENOID BONE. THE BASEPLATE HAD NO FIXATION, THE SURGEON CONVERTED HIS SHOULDER TO A HEMI. EVERYTHING WAS REMOVED EXCEPT THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 848C1098A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 508-00-036, LOT 856C1012| 506-03-118, LOT 832C1017| 506-03-126, LOT 834C1010| 508-36-103, LOT 856C1012| 506-03-122, LOT 833C1021| 508-32-104, LOT 866C1111