BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TOTAL KNEE SYSTEM

    MDR report key: 2427515 · Received January 16, 2012

    Report

    Report Number
    3005180920-2012-00004
    Event Type
    Injury
    Date Received
    January 16, 2012
    Report Date
    January 16, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: EVOLIS PS LINER - REF 3042.0509 / LOT. 020797 (15 PIECES MANUFACTURED). THE MANUFACTURING AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL THE INSERTS OF THE LOT CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MANUFACTURE. ALL THE 15 DEVICES WERE IMPLANTED AND NO OTHER ADVERSE EVENTS WAS REPORTED UP TO NOW. THE RETRIEVED LINER WAS ANALYZED AND IT WAS NOTICED A DEEP WEAR ON THE ANTERIOR ASPECT OF THE PEG. SO, THE BREAKAGE OF THE PS PEG IS PROBABLY DUE TO AN ANTERIOR CONTACT BETWEEN THE PEG AND THE INTERCONDYLAR NOTCH OF THE PT. THIS ISSUE WAS PROBABLY CAUSED BY A BAD PREPARATION OF THE INTERCONDYLAR NOTCH BY THE SURGEON.

    Description of Event or Problem · 1

    A TOTAL KNEE REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE POSTERO-STABILIZATION PEG OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS TOTAL KNEE SYSTEM POSTERO-STABILIZED INSERT 9 MM SIZE 5 JWH MEDACTA INTERNATIONAL SA 020797

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention