BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRON EF

    MDR report key: 724453 · Received June 12, 2006

    Report

    Report Number
    1020279-2006-00530
    Event Type
    Injury
    Date Received
    June 12, 2006
    Report Date
    June 9, 2006
    Manufacturer
    SMITH & NEPHEW INC., ORTHOPAEDIC DIV.
    Product Code
    JDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT REVISION SURGERY DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRON EF FEMORAL COMPONENT JDD SMITH & NEPHEW INC., ORTHOPAEDIC DIV. NA NOT EXACT

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R