BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3781410 · Received April 30, 2014

    Report

    Report Number
    8010764-2014-00017
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260118 R3 R3 36MM ID US CRMC LINER 54 LZO SMITH&NEPHEW, INC 09FT32751

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R