BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERAL RADIAL HEAD PROSTHESIS

    MDR report key: 6099258 · Received November 9, 2016

    Report

    Report Number
    MW5065989
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 9, 2016
    Manufacturer
    SMALL BONE INNOVATIONS INC. / STRYKER CORPORATION
    Product Code
    JDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH MULTIPLE REVISION SURGERY ON LEFT ELBOW HAD A STRYKER LATERAL RADIAL HEAD SIZE 4 PROSTHESIS PLACED DURING LAST REVISION. CURRENT REVISION OF LEFT RADIAL HEAD ARTHROPLASTY NOTED DEVICE FAILURE WITH DELAMINATION OF THE HEAD FROM THE STEM AND FAILURE OF THE TAPER LOCK (PART OF MIDDLE LOCKING MECHANISM ACTUALLY DISENGAGED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742436 LATERAL RADIAL HEAD PROSTHESIS PROSTHESIS, ELBOW JDC SMALL BONE INNOVATIONS INC. / STRYKER CORPORATION 10162-107

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention