BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE TALAR STEM

    MDR report key: 1833019 · Received July 1, 2010

    Report

    Report Number
    1043534-2009-00204
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    May 18, 2009
    Report Date
    June 4, 2009
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2009-00201, 00202, 00203, 00205, 00206, 00207, 00208, 00209.

    Description of Event or Problem · 1

    ORIGINAL IMPLANT; APPROXIMATELY 1 YEAR AGO. REVISED DUE TO RECURRENT ANKLE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INBONE TALAR STEM SMALL JOINT COMPONENT HSN WRIGHT MEDICAL TECHNOLOGY, INC. NA 10157

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R