BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL PS

    MDR report key: 6193104 · Received December 21, 2016

    Report

    Report Number
    3004153240-2016-00250
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 21, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    UDI-DI
    M572TPS1111111011
    PMA / PMN Number
    K142404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844917 ITOTAL PS TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC. M572TPS1111111011

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention