BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED

    MDR report key: 2824158 · Received October 22, 2012

    Report

    Report Number
    3005180920-2012-00067
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 22, 2012
    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 081768 ((B)(4) ITEMS MANUFACTURED). THE ANALYSIS OF THE BATCH RECORD WAS PERFORMED AND EACH MFG STEP WAS DONE FOLLOWING THE SPECIFICATIONS IN FORCE. NO OTHER INCIDENTS WERE REPORTED CONCERNING THIS LOT. EVOLIS TI PLASMA SPRAYED BASEPLATE IN THE USA IS CLEARED UNDER (B)(4) (EVOLIS TOTAL KNEE SYSTEM) AS CEMENTED PROSTHESIS, BUT THE SURGEON IMPLANTED IT WITHOUT CEMENT. IN THE IFU AND SURGICAL TECHNIQUE FOR USA OF EVOLIS, IT 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 USER ERROR.

    Description of Event or Problem · 1

    PT COMPLAINED OF PAIN, AND AFTER EXAMINATION, IT WAS DETERMINED THE TIBIAL BASEPLATE WAS LOOSE. A REVISION SURGERY TO REPLACE THE TIBIAL BASEPLATE AND INSERT WAS SUCCESSFULLY PERFORMED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED TIBIAL BASE PLATE SIZE 3 JWH MEDACTA INTERNATIONAL, SA 081768

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention REF. (B)(4)/ LOT. 090065| EVOLIS TIBIAL INSERT STD SIZE 3-11MM