BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIS CR PRIMARY KNEE SYS

    MDR report key: 4173278 · Received September 24, 2014

    Report

    Report Number
    3005985723-2014-00155
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    JWH
    PMA / PMN Number
    K113122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. REMOVING HARDWARE IS THE RESPONSIBILITY OF OPERATING ROOM STAFF; THEREFORE, THE DEVICE WAS NOT THE CAUSE OF THIS ISSUE. THE CHECKPOINT IS A STERILE DEVICE AND IS MANUFACTURED FROM IMPLANTABLE GRADE MATERIAL. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A TOTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND KINETIS CR IMPLANTS. A CHECKPOINT WAS LEFT IN THE PT FOLLOWING THE SURGERY. WHILE THE PT WAS STILL UNDER ANESTHESIA, THE PT WAS MOVED BACK TO THE OPERATING ROOM AND THE CHECKPOINT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594326 KINETIS CR PRIMARY KNEE SYS KNEE PROSTHESIS, ACCESSORY JWH MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO)