BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2093593 · Received April 14, 2011

    Report

    Report Number
    1644408-2011-00200
    Event Type
    Other
    Date Received
    April 14, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO BEING DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/ RETAINING SCREW KWS ENCORE MEDICAL, L.P. 802C1029

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 508-00-004, LOT 852C1010| 508-00-032, LOT 855C1023