BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 5057520 · Received September 4, 2015

    Report

    Report Number
    3011705391-2015-00170
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 4, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    OOG
    PMA / PMN Number
    K142161
    Removal / Correction Number
    3009844603-8/30/15-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE IJIG INSTRUMENTS WERE WET WHEN REMOVED FROM THE STERILE PACKAGING DURING SURGERY. NO MOISTURE WAS OBSERVED ON IMPLANT COMPONENTS. THE OR STAFF RE-STERILIZED THE IJIGS. SURGERY WAS COMPLETED SUCCESSFULLY. INVESTIGATION CONDUCTED USING KITS IN FINISHED GOODS INVENTORY INDICATES THAT IJIG INSTRUMENTATION MAY CONTAIN SMALL AMOUNTS OF ETHYLENE GLYCOL RESIDUE. CONFORMIS HAS INITIATED A VOLUNTARY RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IJIG INSTRUMENTS WERE WET WHEN REMOVED FROM THE STERILE PACKAGING DURING SURGERY. NO MOISTURE WAS OBSERVED ON IMPLANT COMPONENTS. THE OPERATING ROOM STAFF RE-STERILIZED THE IJIGS. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590146 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM OOG CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR