BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER

    MDR report key: 2102071 · Received April 14, 2011

    Report

    Report Number
    1644408-2011-00198
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE INSERT DID NOT SNAP INTO MONOBLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER PRIMARY HUMERAL SOCKET MONOBLOCK HSD ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 508-00-040, LOT N/A