BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II COCR TIBIAL BASE

    MDR report key: 5001240 · Received August 13, 2015

    Report

    Report Number
    3010536692-2015-01527
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    May 21, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT OCCURRED IN THE (B)(6). THIS IS THE SAME EVENT AS 3010536692-2015-01526, -01528.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION (LEFT). REVISION NJR INDEX NO: 2171600.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534114 ADVANCE(R) II COCR TIBIAL BASE KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. 0411339664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention