BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 863556 · Received June 8, 2007

    Report

    Report Number
    1038671-2007-00032
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    May 9, 2007
    Report Date
    June 8, 2007
    Manufacturer
    EXACTECH, INC.
    Product Code
    FSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT DISLOCATED FROM ANOTHER MANUFACTURER'S REVERSE SHOULDER BEFORE BEING REVISED TO EXACTECH'S REVERSE SHOULDER AND DISLOCATING AGAIN. SPECIFIC DEVICE INFO WAS REQUESTED, BUT NOT PROVIDED. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A TOTAL SHOULDER ARTHROPLASTY WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FSM EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention