BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4036318 · Received August 16, 2014

    Report

    Report Number
    3005985723-2014-00107
    Event Type
    Injury
    Date Received
    August 16, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    KRR
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVAL OF THE EVEN HAS BEEN INITIATED AT MAKO SURGICAL. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED TO THE MAKOPLASTY PROCEDURE NOR THE MCK IMPLANTS. THE PATIENT HAS NOT YET RECEIVED THE SECOND STAGE OF THE REVISION PROCEDURE; THE ANTIBIOTIC REGIMEN IS PLANNED TO THE LAST APPROXIMATELY SIX WEEKS, OR UNTIL THE INFECTION IS CLEARED. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE PATIENT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROXIMATELY FIVE MONTHS LATER, THE PATIENT RECEIVED MED TREATMENT BECAUSE THE INSIDE LAYER OF SUTURES HAD PULLED OUT. THE SURGEON TOOK CULTURES, AND THEN EXCHANGED THE ONLY INSERT COMPONENT AS A PRECAUTION. CULTURES WERE NEGATIVE FOR INFECTION. THE WOUND WAS CLOSED, AND THE PATIENT RETURNED TO NORMAL ACTIVITIES. ABOUT TWO WEEKS LATER, THE PATIENT PRESENTED WITH AN INFECTED KNEE. THE SURGEON CHOSE TO REMOVE THE MCK IMPLANT COMPONENTS AND PERFORM A TWO-STAGE REVISION PROCEDURE (REMOVE IMPLANTS AND IMMOBILIZE THE JOINT WHILE UNDERGOING ANTIBIOTIC TREATMENT, AND FOLLOW WITH A TOTAL KNEE PROCEDURE WHEN THE INFECTION HAS CLEARED). USING A NEW MCK FEMORAL COMPONENT, THE SURGEON CREATED A CEMENT SPACER BY COVERING THE COMPONENT WITH CEMENT AND IMPLANTING THE COMPONENT. THE PATIENT WILL FOLLOW AN ANTIBIOTIC REGIMEN, AND THEN THE SURGEON WILL PROCEED WITH THE SECOND STAGE OF THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492260 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS KRR MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)