BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2163699 · Received June 15, 2011

    Report

    Report Number
    1644408-2011-00336
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 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 PT HAD AN INFECTION. THE DOCTOR WASHED OUT, REMOVED THE HEAD, THE INSERT AND REPLACED THEM WITH NEW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW KWS ENCORE MEDICAL, L.P. 864C1063

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention