BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2092923 · Received May 10, 2011

    Report

    Report Number
    1644408-2011-00270
    Event Type
    Other
    Date Received
    May 10, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD A HEMI SHOULDER REPLACEMENT ABOUT 8 YEARS AGO. THE DR DETERMINED THAT A GLENOID WAS NEEDED. THE HEAD WAS SWAPPED OUT DURING THE GLENOID ADDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER PRIMARY HUMERAL STEM W/MALE TAPER KWS ENCORE MEDICAL, L.P. 221282

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 504-50-022, LOT 881561