BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2011831 · Received February 24, 2011

    Report

    Report Number
    1644408-2011-00100
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY -DUE TO HO/SHOULDER STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW KWS ENCORE MEDICAL, L.P. 871C1001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 508-00-000, LOT 848C1059| 508-00-036, LOT 856C1005