BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2163635 · Received June 8, 2011

    Report

    Report Number
    1644408-2011-00324
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    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 FELL AND DISLOCATED HIS SHOULDER. THE STEM WAS LOOSE, THE DOCTOR REMOVED IT AND REPLACED IT WITH A REVISION SIZE 12 STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER PRIMARY HUMERAL STEM KWS ENCORE MEDICAL, L.P. 816C1034

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention