BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED

    MDR report key: 3716502 · Received February 21, 2014

    Report

    Report Number
    3005180920-2014-00014
    Event Type
    Injury
    Date Received
    February 21, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: EVOLI TI PLASMA SPRAYED BASEPLATE - REF. 3031.0003 / LOT 090715 ((B)(4) ITEMS MANUFACTURED). THE ANALYSIS OF THE BATCH RECORD WAS PERFORMED AND ALL THE PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS IN FORCE AT THE TIME OF THE PRODUCTION. ONE SIMILAR EVENT ON THIS LOT HAS BEEN RECEIVED AND REPORTED TO FDA WITH MDR. EVOLIS TI PLASMA SPRAYED FEMORAL COMPONENT - REF. 3010.006G / LOT. 082374 ((B)(4) ITEMS MANUFACTURED). THE ANALYSIS OF THE BATCH RECORD WAS PERFORMED AND ALL THE PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS IN FORCE AT THE TIME OF THE PRODUCTION. EVOLIS TI PLASMA SPRAYED SYSTEM IN THE USA IS CLEARED UNDER K081023 (EVOLIS TOTAL KNEE SYSTEM) AS CEMENTED PROSTHESIS, BUT THE SURGEON IMPLANTED IT WITHOUT CEMENT (BOTH FEMUR AND TIBIAL BASEPLATE). 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

    REVISION SURGERY PERFORMED DUE TO LOOSENING OF THE TIBIAL BASEPLATE AND OF THE FEMORAL COMPONENT. REF # IMP: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108833 EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED TIBIAL BASE PLATE SIZE 5 JWH MEDACTA INTERNATIONAL, SA 090715

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #082374| EVOLIS TIBIAL INSERT: CODE 3040.0516, LOT #081360| EVOLIS FEMUR TI PLASMA SPRAYED: CODE 3010.006G,