BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 2992998 · Received March 7, 2013

    Report

    Report Number
    1644408-2013-00129
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ENCORE MEDICAL
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT DISLOCATED HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98242 RSP SHOULDER HUMERAL SOCKET SHELL, +4MM OFFSET KWS ENCORE MEDICAL 852C1094

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 508-01-036, LOT 860C1012