BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER SYSTEM

    MDR report key: 1466335 · Received September 4, 2009

    Report

    Report Number
    1644408-2009-00414
    Event Type
    Other
    Date Received
    September 4, 2009
    Date of Event
    August 12, 2009
    Report Date
    August 12, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PT HAD A TOTAL SHOULDER REVISED. ORIGINAL SURGERY, TOTAL RSP IN 2005, 18 MONTHS LATER HAD CENTRAL BASEPLATE SCREW BREAK WITHOUT RESULTS. ON (B)(6) 2009 REVISED TO A HEMI DUE TO GLENOID BONE LOSS AND LOOSENING OF BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER SYSTEM GLENOID BASEPLATE KWS ENCORE MEDICAL, L.P. 267672

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 508-36-003/270792| 506-03-114/242642| 506-03-126/999241| 508-01-036/315292| 506-03-134/228902| 508-00-000/267692