BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3535803 · Received November 20, 2013

    Report

    Report Number
    3005985723-2013-00088
    Event Type
    Other
    Date Received
    November 20, 2013
    Date of Event
    October 2, 2013
    Report Date
    October 2, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO REVISION HAS BEEN PERFORMED TO DATE. THE PT STATED THE SURGEON WHO PERFORMED THE MAKOPLASTY TOLD HER SHE HAD NERVES DAMAGED IN BOTH KNEES DURING SURGERY. SHE MENTIONED HER TKA WAS DONE BY A DIFFERENT SURGEON (NOT A MAKO PROCEDURE). SHE STATED THE SURGEONS SHE HAS SEEN SINCE HER POST-SURGICAL TROUBLES BEGAN HAVE TOLD HER THERE IS NOTHING THEY CAN DO WITH HER KNEES. AS PART OF THE COMPLAINT EVALUATION, THE INSTRUCTIONS FOR USE PROVIDED WITH MAKO IMPLANTS WERE REVIEWED. THESE PRODUCT INSERTS INCLUDE LANGUAGE INFORMING THE USER OF POTENTIAL ADVERSE EFFECTS INCLUDING SENSITIVITY TO COMPONENTS OF KNEE REPLACEMENT SYSTEMS. SESSION FILES FROM THE ORIGINAL MAKOPLASTY PROCEDURE WERE ALSO REVIEWED. ALL VALUES WERE FOUND TO BE WITHIN ACCEPTABLE TOLERANCES AND THERE WAS NO INDICATION OF RIO MALFUNCTION.

    Description of Event or Problem · 1

    THE PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, PERFORMED USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK). PT CALLED TO INQUIRE INTO THE TYPE OF METAL USED IN OUR IMPLANTS. PT STATED THAT SHE IS HAVING INFLAMMATION AND PAIN IN HER LEFT KNEE, ON WHICH SHE HAD MAKOPLASTY IN (B)(6) 2011, AND HER RIGHT KNEE, ON WHICH SHE HAD TKA EARLIER IN 2011. SHE FEARS SHE IS ALLERGIC TO METAL AND NOT SURE WHAT TO DO, BUT MENTIONED THAT HER HOSPITAL RECOMMENDED A METAL ALLERGY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604285 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180502 2645081101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)