BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM

    MDR report key: 3433395 · Received October 28, 2013

    Report

    Report Number
    1020279-2013-00537
    Event Type
    Injury
    Date Received
    October 28, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PROGRESSIVE DJD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550870 TANDEM FEMORAL COMPONENT JDH SMITH & NEPHEW, INC. 11CM00915

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R