BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLECTION

    MDR report key: 3100278 · Received May 8, 2013

    Report

    Report Number
    1020279-2013-00251
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN PRINT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON WAS UNABLE TO ASSEMBLE THE DEVICE, CAUSING A DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201963 REFLECTION FEMORAL COMPONENT JDH SMITH & NEPHEW, INC. 12CM09188

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R