BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II COCR TIBIAL BASE

    MDR report key: 3842738 · Received June 2, 2014

    Report

    Report Number
    3010536692-2014-00873
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    PMA / PMN Number
    K960617
    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 SHOWS NO TREND FOR ITEM/LOT.

    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 IS THE SAME EVENT AS 3010536692-2014-00874 AND 00875. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY: REVISION WAS BECAUSE IMPLANT WAS MALROTATED. AN ADVANCE CCK WAS IMPLANTED AT THE REVISION OF THIS TKR. ORIGINAL SURGERY 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320793 ADVANCE(R) II COCR TIBIAL BASE KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention