BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY POSTERIOR STABILIZING KRS

    MDR report key: 16380500 · Received February 15, 2023

    Report

    Report Number
    3004153240-2023-00009
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    January 24, 2023
    Report Date
    February 15, 2023
    Manufacturer
    CONFORMIS INC
    Product Code
    JWH
    PMA / PMN Number
    K201023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE HAVE BEEN NO OTHER REPORTS OF PROCEDURAL OR POST-OPERATIVE COMPLICATIONS FOR THIS PATIENT. ORIGINAL SURGERY DATE WAS (B)(6)2022. REVISION SURGERY WAS (B)(6) 2023. CAUSE OF INFECTION IS UNKNOWN. NCMR'S WERE REVIEWED. THE DEVICE WAS SHIPPED UNDER BI QUARANTINE (TQ-23-0013) BUT USED ONLY AFTER PASSING RESULTS. THE RISK ANALYSIS WAS REVIEWED. INFECTION IS A KNOWN RISK OF TOTAL KNEE REPLACEMENT SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER THE PRIMARY SURGERY. ORIGINAL SURGERY DATE WAS (B)(6) 2022. REVISION SURGERY WAS (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291036 ITOTAL IDENTITY POSTERIOR STABILIZING KRS KNEE REPLACEMENT SYSTEM JWH CONFORMIS INC TPS-101-1112-020101

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Required Intervention| H