BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    MDR report key: 3905151 · Received July 1, 2014

    Report

    Report Number
    3010536692-2014-00925
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    February 13, 2003
    Report Date
    June 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    PMA / PMN Number
    K960617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6). THIS IS THE SAME EVENT AS 3010536692-2014-00924 AND 00926.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO TOTAL SEPTIC LOOSENING (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382390 ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. 01215742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention