BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) TOT COND FEMORAL NON-POROUS

    MDR report key: 3467790 · Received November 13, 2013

    Report

    Report Number
    1043534-2013-02116
    Event Type
    Injury
    Date Received
    November 13, 2013
    Date of Event
    July 18, 2011
    Report Date
    October 18, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K974328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-02117 AND 1043534-2013-02118. THIS EVENT OCCURRED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (B)(6) 2017. UPDATED EXPLANT DATE( (B)(6) 2011), AND REVISION NJR NUMBER . REVISION NJR INDEX NO: (B)(4). PRIMARYASA P2- MILD DISEASE NOT INCAPACITATING.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586901 ADVANCE(R) TOT COND FEMORAL NON-POROUS KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 097472356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention