BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL PS

    MDR report key: 5049588 · Received September 2, 2015

    Report

    Report Number
    3011705391-2015-00167
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 1, 2015
    Report Date
    September 2, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON CONVERTED OUT OF THE ITOTAL PS KNEE TO AN OTS KNEE SYSTEM DURING THE PRIMARY PROCEDURE. THIS ADDED ONE HOUR TO THE SURGERY TIME. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE SURGEON CONVERTED OUT OF THE ITOTAL PS KNEE TO AN OTS KNEE SYSTEM DURING THE PRIMARY PROCEDURE. THIS ADDED ONE HOUR TO THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581732 ITOTAL PS TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR