BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) TIBIAL STEM CANAL

    MDR report key: 3774497 · Received April 26, 2014

    Report

    Report Number
    3010536692-2014-00715
    Event Type
    Injury
    Date Received
    April 26, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS 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

    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 3010536692-2014-00712, 00713, 00714, AND 00716.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY A REVISION FOR SUSPECTED ASEPTIC LOOSENING OF THE TIBIA . TIBIAL LUCENCY SEEN LATERALLY ON TIBIA. ON OPENING THE KNEE FEMUR WAS ALSO LOOSE AND DISSOCIATION OF FEMORAL STEM FROM FEMUR. FEMORAL STEM DISASSOCIATION NOT VISIBLE ON X-RAY. NO IMPACTION MARKS SEEN ON THE FEMORAL STEM WHEN REMOVED. DE-BONDING OF THE CEMENT FROM THE TIBIAL TRAY FROM POSTERIOR MEDIAL SIDE. OPEN JOINT LINE WITH 20MM SPACER AT REVISION. JOINT LINE RESTORED WITH THE USE OF A SIZE 3 CCK FEMUR. THE TIBIAL TRAY DISTAL AUGMENTS X 2 10MM FEMUR. TIBIAL AUGMENTS X 2 10MM. USE OF A 12MM CCK POLY INSERT. MEDIUM ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252927 ADVANCE(R) TIBIAL STEM CANAL KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. 04484076

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention