BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3923768 · Received July 9, 2014

    Report

    Report Number
    8010764-2014-00032
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401523 R3 CERAMIC FEMORAL COMPONENT LZO SMITH&NEPHEW, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R