BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER SYSTEM

    MDR report key: 1063712 · Received June 20, 2008

    Report

    Report Number
    1644408-2008-00194
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - HEAD DISLOCATED OFF OF THE HUMERAL STEM, OSTEOPHYTES FOUND AROUND HUMERAL STEM WHICH DIDN'T ALLOW HEAD TO SEAT COMPLETELY, PER THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER SYSTEM HUMERAL HEAD HSD ENCORE MEDICAL, L.P. 53888266

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention