BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 1981282 · Received February 2, 2011

    Report

    Report Number
    1644408-2011-00054
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K950594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - AFTER HER PRIMARY TOTAL SHOULDER REPLACEMENT, THE PATIENT TORE HER SUBSCAPULARIS. THE SURGEON REPLACED THE HEAD WITH A SMALLER SIZE AND REPAIRED THE SUBSCAPULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER STANDARD HUMERAL HEAD W/FEMALE TAPER HSD ENCORE MEDICAL, L.P. 53988058

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention