BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4044759 · Received August 15, 2014

    Report

    Report Number
    3005985723-2014-00105
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. DUE TO THE LONG PERIOD OF TIME BETWEEN THE PATIENT'S PROCEDURE AND THE APPEARANCE OF THE RASH, IT IS NOT BELIEVED THAT THE MCK IMPLANTS NOR THE MAKO PLASTY PROCEDURE CONTRIBUTED TO THE PATIENT'S CONDITION. A RESPONSE WILL BE PROVIDED TO THE PATIENT WITH THE MATERIAL COMPOSITION OF THE IMPLANTS, AS WELL AS A RECOMMENDATION TO CONSULT WITH A MAKOPLASTY PHYSICIAN. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE PATIENT HAD RECEIVED BILATERAL PARTIAL KNEE ARTHROPLASTY PROCEDURES USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. THE PATIENT CONTACTED MAKO SURGICAL INQUIRING ABOUT THE MATERIAL COMPOSITION OF THE MCK IMPLANTS. IN (B)(6) 2014, ALMOST A YEAR FOLLOWING THE ORIGINAL PROCEDURE, THE PATIENT BEGAN EXPERIENCING A SKIN RASH NEAR THE BASE OF THE SKULL, WHICH THEN SPREAD TO THE PATIENT'S LEGS AND BACK. THE PATIENT HAS SOUGHT MEDICAL ATTENTION, AND SEVERAL ANTIHISTAMINES HAVE FAILED TO RELIEVE HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490252 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL

    Patients

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