BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTE

    MDR report key: 3240224 · Received July 22, 2013

    Report

    Report Number
    8010764-2013-00034
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SMITH&NEPHEW -GERMANY
    Product Code
    LPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. IMPLANTED IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339655 FORTE R3 32MM ID US CRMC LINER 48 LPF SMITH&NEPHEW -GERMANY 09BT29146

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R