BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED

    MDR report key: 2253532 · Received September 9, 2011

    Report

    Report Number
    3005180920-2011-00049
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    September 9, 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 - REF (B)(4)/LOT 081152. THE ANALYSIS OF THE BATCH RECORDS WAS DONE AND NO ANOMALIES WERE FOUND CONCERNING THE PROBLEM OCCURRED. EVOLIS TI PLASMA SPRAYED BASEPLATE IN THE (B)(6) IS CLEARED UNDER K081023 (EVOLIS TOTAL KNEE SYS) AS CEMENTED PROSTHESIS, BUT THE SURGEON IMPLANTED IT WITHOUT CEMENT. IN THE IFU AND SURGICAL TECHNIQUE FOR US 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 SYS. THE EVENT IS NOT DEVICE RELATED, BUT DUE TO A USE ERROR.

    Description of Event or Problem · 1

    THE TIBIAL BASEPLATE CAME LOOSE. PRIMARY SURGERY WA SON (B)(6) 2009. THE TIBIAL BASEPLATE AND THE TIBIAL INSERT WERE EXPLANTED AND REPLACED WITH REVISION COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED TIBIAL BASE PALTE SIZE 2 JWH MEDACTA INTERNATIONAL, SA 081152

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention REF (B)(4)/LOT 081342| EVOLIS TIBIAL INSERT SIZE 2 - 9 MM