BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS TOTAL KNEE SYSTEM

    MDR report key: 2613869 · Received February 19, 2010

    Report

    Report Number
    3005180920-2010-00004
    Event Type
    Injury
    Date Received
    February 19, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 22, 2010
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER LOT OF RECALLED PRODUCT WAS DISTRIBUTED TO THE USA. THE RECALL WAS REPORTED BY (B)(6) TO (B)(6) AND (B)(6). FIELD SAFETY CORRECTIVE ACTION, MEDICAL DEVICE VIGILANCE SYSTEM ((B)(4)). CIRCULAR LETTER N. (B)(4). REPORT FORM, MANUFACTURER'S INCIDENT REPORT, MEDICAL DEVICES VIGILANCE SYSTEM ((B)(4)).

    Description of Event or Problem · 1

    A PT UNDERWENT A TOTAL KNEE ARTHROPLASTY PLANNING TO IMPLANT A SIZE 5 (RIGHT) FEMORAL COMPONENT. IN THE FINAL PART OF THE SURGERY, A BOX THAT WAS LABELED AS A FEMORAL COMPONENT STANDARD SIZE 5D (RIGHT) WAS OPENED AND IN THE BOX THERE WAS A FEMORAL COMPONENT STANDARD SIZE 1G (LEFT). THE SURGEON DID NOT HAVE ANOTHER FEMUR OF THE SAME KIND TO SUBSTITUTE SO A POSTERO-STABILIZED FEMUR SIZE 5D (RIGHT) WAS IMPLANTED I THE PT AS IT WAS READILY AVAILABLE AT THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS TOTAL KNEE SYSTEM FEMORAL COMPONENT STANDARD SIZE5 RIGHT JWH MEDACTA INTERNATIONAL, SA NA 080795

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention (B)(4), LOT 080793| FEMORAL COMPONENT STANDARD SIZE 1G (LEFT):