BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL IDENTITY CR

    MDR report key: 11668123 · Received April 14, 2021

    Report

    Report Number
    3004153240-2021-00057
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 13, 2021
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    UDI-DI
    M572TCR3011113011
    PMA / PMN Number
    K190562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD TIBIAL EROSION WITHIN THE LATERAL COMPARTMENT OF THEIR TIBIA DISCOVERED DURING THE PLANNING FOR THEIR ITOTAL KNEE REPLACEMENT. CONFORMIS ENGINEERING AND THE SURGEON REVIEWED THE CASE AND DEEMED THAT THE PATIENT WOULD NOT BE A CANDIDATE FOR AN ITOTAL IMPLANT. THE SALES AGENT CONTACTED CUSTOMER SERVICE VIA PHONE TO CANCEL THE CASE, BUT DID NOT SUBMIT THE CANCELLATION IN WRITTEN/ EMAIL FORM AS WAS REQUESTED BY CUSTOMER SERVICE. WITHOUT THE CANCELLATION INITIATED, THE CASE CONTINUED THROUGH PRODUCTION AND WAS SENT TO THE HOSPITAL FOR THE PROCEDURE. THE SURGEON PROCEEDED WITH THE CASE AND FOUND THAT THE TIBIAL BASE PLATE COULD NOT PROVIDE ADEQUATE COVERAGE WITHIN THE LATERAL PORTION OF THE TIBIA AND WAS UNSTABLE IN FLEXION. A STRYKER TIBIAL BASE PLATE WAS UTILIZED ALONG WITH THE CONFORMIS FEMORAL COMPONENT AND CONFORMIS CUTTING GUIDES. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. RETRAINING OF THE SALES TEAM IS UNDERWAY TO ENSURE THAT CANCELLATIONS ARE PROVIDED TO CUSTOMER SERVICE IN WRITTEN/ EMAIL FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TIBIAL EROSION WITHIN THE LATERAL COMPARTMENT OF THEIR TIBIA DISCOVERED DURING THE PLANNING FOR THEIR ITOTAL KNEE REPLACEMENT. CONFORMIS ENGINEERING AND THE SURGEON REVIEWED THE CASE AND DEEMED THAT THE PATIENT WOULD NOT BE A CANDIDATE FOR AN ITOTAL IMPLANT. THE SALES AGENT CONTACTED CUSTOMER SERVICE VIA PHONE TO CANCEL THE CASE, BUT DID NOT SUBMIT THE CANCELLATION IN WRITTEN FORM AS WAS REQUESTED BY CUSTOMER SERVICE. WITHOUT THE CANCELLATION INITIATED, THE CASE CONTINUED THROUGH PRODUCTION AND WAS SENT TO THE HOSPITAL FOR THE PROCEDURE. THE SURGEON PROCEEDED WITH THE CASE AND FOUND THAT THE TIBIAL BASE PLATE COULD NOT PROVIDE ADEQUATE COVERAGE WITHIN THE LATERAL PORTION OF THE TIBIA AND WAS UNSTABLE IN FLEXION. A STRYKER TIBIAL BASE PLATE WAS UTILIZED ALONG WITH THE CONFORMIS FEMORAL COMPONENT AND CONFORMIS CUTTING GUIDES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560115 ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC. TCR301111301 M572TCR3011113011

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR