BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 1912901 · Received November 11, 2010

    Report

    Report Number
    1644408-2010-00604
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K960906
    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 PATIENT TORE HIS SUBSCAPULARIS (WHICH IS IRREPARABLE) AFTER THE INITIAL TS SURGERY, THE SHOULDER BECAME UNSTABLE AND PAINFUL. THE SURGEON NEEDED TO REVISE TO A REVERSE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER UNIFORM PEGGED GLENOID KWS ENCORE MEDICAL, L.P. 742C1002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 504-50-022, LOT 53998382| 503-00-010, LOT 54042122