BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    MDR report key: 3774476 · Received April 26, 2014

    Report

    Report Number
    3010536692-2014-00714
    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
    Adverse Event
    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. (B)(4).

    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, 00715, AND 00716.

    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. 3 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
    252955 ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. 056342186

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention