BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FIX

    MDR report key: 2992662 · Received March 7, 2013

    Report

    Report Number
    1020279-2013-00149
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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 PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97053 OPTI-FIX FEMORAL COMPONENT JDH SMITH & NEPHEW, INC. OR71740854 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization