BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4251797 · Received November 6, 2014

    Report

    Report Number
    3005985723-2014-00182
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    KRR
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST THAT THE RIO OR MCK IMPLANTS CONTRIBUTED TO THE INFECTION. IT WAS ALSO NOTED FROM THE SURGEON THAT THE PT WILL EVENTUALLY UNDERGO A TOTAL KNEE REPLACEMENT SURGERY. ADDITIONAL FOLLOW UP WAS OBTAINED FROM THE SURGEON APPROXIMATELY TWO WEEKS LATER. THE SURGEON REMOVED THE IMPLANTS AND PLACED A CEMENT SPACER IN THE KNEE JOINT.

    Description of Event or Problem · 1

    A PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. A MONTH LATER, THE PT DEVELOPED A STAPH INFECTION, AND THE SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) PROCEDURE AND EXCHANGED THE TIBIAL ONLAY INSERT COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714263 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS KRR MAKO SURGICAL

    Patients

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