BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 3786893 · Received April 21, 2014

    Report

    Report Number
    3005985723-2014-00043
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    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 EVAL OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. THE SURGEON STATED HE WILL LEAVE THE CEMENT SPACER IN PLACE FOR 6 WEEKS AND THEN RE-EVALUATE WHETHER EITHER A PKA OR TKA REVISION WILL BE REQUIRED. HE SAID THE INFECTION MAY DAMAGE THE REST OF THE KNEE. THE FUNGAL INFECTION OCCURRED MORE THAN 18 MONTHS AFTER THE ORIGINAL PARTIAL KNEE PROCEDURE. AT THIS TIME THERE IS NO EVIDENCE TO SUGGEST THAT THE RIO OR MCK IMPLANTS CONTRIBUTED TO THE INFECTION. THE EVAL IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    A PT HAS RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. THE PT DEVELOPED A FUNGAL INFECTION SO ON THE DATE OF EVENT, THE SURGEON REMOVED THE RESTORIS MCK IMPLANTS AND REPLACED THEM WITH A CEMENT SPACER. THE CEMENT SPACER WAS CREATED BY THE SURGEON WITH THE USE OF A RESTORIS MCK TIBIAL ONLAY INSERT ENCLOSED IN CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242004 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL CORP. 180703-1 12260212-1

    Patients

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