BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP

    MDR report key: 1853247 · Received September 30, 2010

    Report

    Report Number
    1644408-2010-00509
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAS UNDERGONE MULTIPLE SURGERIES ON THIS SHOULDER. THE LAST SURGERY REQUIRED THE USE OF 44 +8 GLENOSPHERE. RECENTLY, THE MORSE TAPER DISENGAGED AND A REVISION WAS REQUIRED TO FIX IT. THE SHELL, INSERT AND GLENOSPHERE WERE REMOVED AND A NEW 44 +8 SHELL WITH A STANDARD LINER AND +4 SHELL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP GLENOID HEAD KWS ENCORE MEDICAL, L.P. 54041856

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention