BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEAD; RHEAD RADIAL HEAD IMPLANT

    MDR report key: 3874027 · Received June 5, 2014

    Report

    Report Number
    3003640913-2014-00044
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    August 30, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KWI
    PMA / PMN Number
    K011819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: MODEL #: RHA-S4. SURGERY REPORT AND PATIENT FILMS WERE REVIEWED AND INDICATE THAT THE IMPLANT LOOSENING WAS DUE TO IMPROPER PROCEDURE AT PRIMARY SURGERY.

    Description of Event or Problem · 1

    APPARENT LOOSENING OF THE RHEAD RADIAL STEAM IMPLANT AND AXIAL ROTATION FROM THE UNI-ELBOW RADIO CAPITELLUM SYSTEM WAS REPORTED. A MALFUNCTION OF THIS TYPE WILL MOST LIKELY REQUIRE A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329419 RHEAD; RHEAD RADIAL HEAD IMPLANT PROSTHESIS,ELBOW,HEMI,RADIAL,POLYMER KWI SMALL BONE INNOVATIONS, INC. 410-0006

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other