BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVERSE SHOULDER SYSTEM

    MDR report key: 1053022 · Received May 27, 2008

    Report

    Report Number
    1644408-2008-00159
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - GLENOID BASEPLATE AND HUMERAL IMPLANTS WERE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE KWS ENCORE MEDICAL, L.P. 53864976

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 506-03-138/53809499 2EA| 508-00-000/53867956| 508-32-103/53864974| 508-00-032/53860788| 506-03-118/53854147| 506-00-007/53838475