BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE II COCR TIBIAL BASE

    MDR report key: 1021981 · Received March 28, 2008

    Report

    Report Number
    1043534-2008-00049
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 10, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRY
    PMA / PMN Number
    K960617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE. A MEDWATCH 3500A HAS NOT BEEN REC'D FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00047, 00048, 00050.

    Description of Event or Problem · 1

    ALLEGEDLY, REVISED DUE TO SEVERE HYPEREXTENSION OF THE LEFT KNEE WITH SIGNIFICANT STRETCHING OF THE POSTERIOR CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE II COCR TIBIAL BASE HRY WRIGHT MEDICAL TECHNOLOGY, INC. 085265745

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R