BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM, 6MM

    MDR report key: 718135 · Received May 24, 2006

    Report

    Report Number
    1220246-2006-00064
    Event Type
    Injury
    Date Received
    May 24, 2006
    Date of Event
    November 19, 2005
    Report Date
    May 22, 2006
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWJ
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED THE UNIVERS TOTAL SHOULDER IN 03 AS PART OF A REVISION OF HEMIARTHROPLASTY FROM 1987. RECOVERY FROM PROCEDURE WAS UNCOMPLICATED AND OVERALL EXCELENT. SURGEON REPORTS FATIGUE, OCCASIONAL SORENESS BUT TREMENDOUSLY BETTER THAN PREOP. IN 2005, PATIENT DEVELOPED PAIN IN SHOULDER, AS PATIENT REACHED FOR AN OVERHEAD ITEM AT WORK. FORWARD ELEVATION DEGREE REDUCED AFTER THE INCIDENT. RADIOGRAPHS DEMONSTRATE ROTATION OF HEAD TO AN INFERIOR OFFSET, DIFFERENT THAN PREVIOUS X-RAYS. A REVISION SURGERY WAS REQUIRED. THE STEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S STEM. POST OPERATIVE COURSE HAS BEEN UNEVENTFUL. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL STEM, 6MM HUMERAL STEM, (3D TOTAL SHOULDER SYSTEM) KWJ ARTHREX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *