BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP

    MDR report key: 1230286 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00415
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD DEVELOPED AN INFECTION IN HER SHOULDER. THE PT HAD THE EXISTING SHELL AND INSERT REMOVED, AND I&D WAS PERFORMED. A 32MM SEMICONSTRAINED HUMERAL SOCKET INSERT AND +4MM OFFSET SHELL WERE REINSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP HUMERAL SOCKET SHELL HSD ENCORE MEDICAL, L.P. 53943847

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOT# 53930061