BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 2973539 · Received February 14, 2013

    Report

    Report Number
    3004153240-2013-00018
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECT IMPLANT KIT WAS OPENED FOR A BILATERAL TOTAL KNEE REPLACEMENT. THE RIGHT KNEE IMPLANT KIT WAS SHIPPED AND OPENED AND THE SURGERY WAS SCHEDULED FOR THE LEFT KNEE. THE PT WAS UNDER ANESTHESIA AND THE LEFT KNEE WAS INCISED AT THE TIME THE ERROR WAS REALIZED. SURGERY WAS RESCHEDULED. REVIEW INDICATES THAT SHIPPED IMPLANT KIT WAS CORRECTLY IDENTIFIED AS RIGHT KNEE IMPLANT.

    Description of Event or Problem · 1

    INCORRECT IMPLANT KIT WAS OPENED FOR BILATERAL TOTAL KNEE REPLACEMENT. THE RIGHT KNEE IMPLANT KIT WAS SHIPPED AND OPENED IN THE SURGERY AND SCHEDULED FOR THE LEFT KNEE. THE PT WAS UNDER ANESTHESIA AND THE LEFT KNEE INCISED AT THE TIME THE ERROR WAS REALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66299 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR