BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 6028297 · Received October 13, 2016

    Report

    Report Number
    3004153240-2016-00197
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 13, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN DUE TO SCAR TISSUE. IT WAS ALSO REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN DUE TO SCAR TISSUE. IT WAS ALSO REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676970 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention