BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED

    MDR report key: 1971424 · Received January 14, 2011

    Report

    Report Number
    3005180920-2011-00002
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 13, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Product Problem
    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. 090715. THE ANALYSIS OF THE BATCH RECORD WAS PERFORMED AND ALL THE PARAMETERS WERE FOUND CONFORMING TO THE SPECIFICATIONS. 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 INDICATED 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 USE ERROR.

    Description of Event or Problem · 1

    A 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 NA 090715

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention