BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY PS KNEE REPLACEMENT SYSTEM

    MDR report key: 16273374 · Received January 31, 2023

    Report

    Report Number
    3004153240-2023-00004
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 17, 2023
    Report Date
    January 30, 2023
    Manufacturer
    CONFORMIS INC.
    Product Code
    JWH
    UDI-DI
    M572TPS1011112011
    PMA / PMN Number
    K203447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER THE PRIMARY SURGERY WHICH WAS DONE (B)(6). THERE HAVE BEEN NO OTHER REPORTS OF PROCEDURAL OR POST-OPERATIVE COMPLICATIONS FOR THIS PATIENT. THE NCMR RECORDS FOR THIS PATIENT WERE REVIEWED. TQ-22-0031 WAS NOTED BUT WAS CLEARED PRIOR TO SURGERY BEING PERFORMED. NO DESIGN RELATED NCMRS NOTED. THE DEVICE WAS MANUFACTURED AND PROCESSED THROUGH LTS-V DONE ON 02/07/2022. ALL CYCLES WERE COMPLETED WITHOUT ISSUES. REVIEW INDICATES THAT THE DEVICE WAS DESIGNED AND MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET. INFECTION IS A KNOWN COMPLICATION OF JOINT REPLACEMENT SURGERY. CAUSE OF INFECTION CANNOT BE CONCLUSIVELY DETERMINED WITH AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE SURGEON HAS ORDERED THE FOLLOWING REPLACEMENT PARTS FOR INTENDED REVISION SURGERY. ITOTAL IDENTITY PS TIBIAL INSERT 10MM RIGHT. ITOTAL IDENTITY PS TIBIAL INSERT,, 6MM, RIGHT. ITOTAL IDENTITY PS TIBIAL INSERT, 8MM, RIGHT. ORIGINAL SURGERY DATE: (B)(6) 2022. NEW SURGERY DATE: (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105747 ITOTAL IDENTITY PS KNEE REPLACEMENT SYSTEM KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED JWH CONFORMIS INC. TPS101111201 M572TPS1011112011

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention| H