BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL PROSTHESIS

    MDR report key: 3670367 · Received February 26, 2014

    Report

    Report Number
    3005985723-2014-00014
    Event Type
    Injury
    Date Received
    February 26, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. ACCORDING TO THE SURGEON, THE ORIGINAL MEDIAL IMPLANT COMPONENTS ARE INTACT AND PLACED WELL, WITH NO LOOSENING NOTED. THIS REPORT IS BEING FILED BASED ON THE INCISION AND DRAINAGE PROCEDURE PERFORMED TO ADDRESS THE INFECTION. NO EVIDENCE SUGGESTS THAT THE INFECTION WAS DUE TO ANY MAKO PRODUCT. THE SURGEON STATED THAT THIS PATIENT MAY HAVE PAIN DUE TO CHRONIC INFECTION.

    Description of Event or Problem · 1

    A SURGEON INFORMED MAKO SURGICAL THAT HE MAY HAVE TO REVISE A PATIENT WHO UNDERWENT A PARTIAL KNEE ARTHROPLASTY CASE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE IMPLANTS. THE REVISION WAS PLANNED DUE TO PROGRESSION OF THE JOINT DISEASE TO THE PATELLOFEMORAL COMPONENT; THE MEDIAL UNICOMPARTMENTAL IMPLANTS WERE REPORTED TO BE IN GOOD PLACEMENT. DUE TO AN INFECTION OF THE JOINT, THE SURGEON PERFORMED AN INCISION AND DRAINAGE PROCEDURE AND DECIDED AGAINST THE REVISION. A TOTAL KNEE REVISION MAY BE PERFORMED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117408 RESTORIS MULTICOMPARTMENTAL PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL

    Patients

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