BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TOTAL KNEE SYSTEM

    MDR report key: 2613841 · Received February 19, 2010

    Report

    Report Number
    3005180920-2010-00003
    Event Type
    Injury
    Date Received
    February 19, 2010
    Date of Event
    November 1, 2009
    Report Date
    November 26, 2009
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS AND QUALITY DOCUMENTS WERE REVIEWED. THE MFG AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL POSTERO STABILIZED CEMENTED FEMURS RELEASED TO THE FIELD OF LOT NUMBER 021206 (8 MFG AND 4 SENT TO (B)(6), 2 TO (B)(6), 2 TO (B)(6)) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MFR, INCLUDING DIMENSIONAL AND SHAPE VALUES. THE MFG AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL POSTERO STABILIZED INSERTS RELEASED TO THE FIELD OF LOT NUMBER 021153 (5 MFG AND 2 SENT TO (B)(6), 2 TO (B)(6), 1 TO (B)(6)) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MFR, INCLUDING DIMENSIONAL SHAPE VALUES. THE MFG AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL TIBIAL BASEPLATES RELEASED TO THE FIELD OF LOT NUMBER 031571 (30 MFG AND 2 SENT TO (B)(6), 4 TO (B)(6), 1 TO (B)(6), 23 TO (B)(6)) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MFR, INCLUDING DIMENSIONAL AND SHAPE VALUES. THE DEVICE HAS BEEN RETURNED AND AN INVESTIGATION INTO THE ROOT CAUSE AND POSSIBLE CORRECTIVE ACTION IS IN PROGRESS BUT NOT COMPLETE AT THIS TIME.

    Description of Event or Problem · 1

    A TOTAL KNEE REVISION SURGERY WAS PERFORMED APPROX. FIVE YEARS FROM THE PRIMARY SURGERY. THE REVISION WAS REQUIRED 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 9MM SIZE 5 JWH MEDACTA INTERNATIONAL, SA NA 021153

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PS CEMENTED FEMUR SIZE 5 RIGHT: (B)(4),| LOT 021206| CEMENTED TIBIAL BASEPLATE SIZE 5: (B)(4),| LOT 031571