BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS CEMENTED TIBIAL BASE PLATE SIZE 2

    MDR report key: 3242420 · Received July 17, 2013

    Report

    Report Number
    3005180920-2013-00083
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: EVOLIS CEMENTED TIBIAL BASEPLATES SIZE 2- REF (B)(4)/LOT 125621 (22 ITEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFR, INCLUDING WASHING AND STERILIZATION CYCLES. THIRTEEN TIBIAS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAD BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED. THE SITUATION IS STILL UNDER EVAL BY THE SURGEON AND A FOLLOW UP WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    REF IMP NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332956 EVOLIS CEMENTED TIBIAL BASE PLATE SIZE 2 KNEE TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1