BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUINOXE

    MDR report key: 2633020 · Received June 20, 2012

    Report

    Report Number
    1038671-2012-00077
    Event Type
    Other
    Date Received
    June 20, 2012
    Date of Event
    May 9, 2012
    Report Date
    June 20, 2012
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICES HAVE NOT BEEN RETURNED TO MFR FOR EVAL.

    Description of Event or Problem · 1

    REVISION OF LEFT SHOULDER COMPONENTS DUE TO INFECTION. THE STEM WAS CEMENTED WHEN INITIALLY PLACED. THERE WAS A SUBSTANTIAL AMOUNT OF INFECTION FOUND IN THE GLENOSPHERE ITSELF AND ALSO AROUND THE SCREWS OF THE GLENOID PLATE. LESS INFECTION ASSOCIATED WITH THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUINOXE REVERESE SHOULDER COMPONENTS HSD EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention