BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLECTION

    MDR report key: 2943855 · Received February 5, 2013

    Report

    Report Number
    1020279-2013-00070
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ALL CRITICAL INTERLOCKING DIMENSIONS WERE CHECKED. NO FEATURES WERE FOUND TO BE OUT OF THE PRINT SPECIFICATION. THERE ARE TWO NOTICEABLE MARKS ON THE OUTSIDE RADIUS WHICH APPEAR TO BE SCREW HEADS OR HOLE PLUGS INDENTATIONS. THE INTERFERENCE COULD KEEP THE LINER FROM SEATING INTO THE SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY WAS DELAY DUE TO THE SURGEON HAVING TROUBLE INSERTING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48582 REFLECTION FEMORAL COMPONENT JDG SMITH & NEPHEW, INC. 12HM00386

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization