BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4251777 · Received November 7, 2014

    Report

    Report Number
    3005985723-2014-00187
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    May 25, 2012
    Report Date
    October 14, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    KRR
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A BIOCOMPARTMENTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS ON (B)(6) 2012. THE PT LATER COMPLAINED OF KNEE PAIN. FIVE MONTHS FOLLOWING THE SURGERY, THE PATIENT SAW A DIFFERENT SURGEON WHO DID A X-RAY THAT SHOWED "METAL O METAL" AND A DISLODGED INSERT COMPONENT. ON (B)(6) 2014 THE PT UNDERWENT A TOTAL KNEE REVISION SURGERY. FOLLOWING THE REVISION PROCEDURE, THE PATIENT WAS INFORMED THAT THE SURGICAL TEAM WAS "UNABLE TO REMOVE ALL THE METAL SCRAPINGS". THE PT REPORTS "PAIN, SWELLING AND INFLAMMATION" AS WELL AS DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719280 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS KRR MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)