BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LAT DISTAL FEM

    MDR report key: 3250993 · Received July 29, 2013

    Report

    Report Number
    8010764-2013-00037
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO FRACTURED PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352904 4.5MM LAT DISTAL FEM PERI-LOC 4.5MM TI L-D FEM PL 6H R 155MM HRS SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R