BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED

    MDR report key: 1970120 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00030
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 16, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: EVOLIS TI PLASMA SPRAYED BASEPLATE - (B)(4)/LOT. 081766. EVOLIS TIBIAL INSERT - (B)(4)/LOT. 081751. THE ANALYSIS OF THE BATCH RECORDS OF LOTS 081766 (BASE PLATE) AND 081751 (PE TIBIAL INSERT) WERE PERFORMED AND ALL THE PARAMETERS WERE FOUND CONFORMING TO THE SPECIFICATIONS. FAILURE INVESTIGATIONS AND CONCLUSIONS: EVOLIS TI PLASMA SPRAYED BASEPLATE IN USA IS CLEARED UNDER K081023 (EVOLIS TOTAL KNEE SYSTEM) AS CEMENTED PROSTHESIS, BUT THE SURGEON IMPLANTED IT WITHOUT CEMENT. IN THE IFU AND SURGICAL TECHNIQUE FOR USA OF EVOLIS IS CLEARLY INDICATE THAT THE PRODUCT IS TO BE CEMENTED. WITHOUT USING CEMENT, IT IS KNOWN THAT THE RISK OF LOOSENING IS HIGHER THAN CEMENTED SYSTEMS. THE EVENT IS NOT DEVICE RELATED, BUT DUE TO A USER ERROR.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIAL BASEPLATE: A CEMENTED BASEPLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED TIBIAL BASE PLATE JWH MEDACTA INTERNATIONAL SA 081766

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EVOLIS TIBIAL INSERT- REF. (B)(4)/LOT. 081751