BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FIX

    MDR report key: 2173048 · Received July 23, 2011

    Report

    Report Number
    1020279-2011-00273
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 25, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    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 WAS REPORTED DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FIX LINER JDH SMITH & NEPHEW, ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R