BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 3070104 · Received April 22, 2013

    Report

    Report Number
    1644408-2013-00223
    Date Received
    April 22, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171641 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT, +4MM KWS ENCORE MEDICAL, L.P. 919F1009

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention