BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2644884 · Received June 29, 2012

    Report

    Report Number
    3005985723-2012-00177
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 30, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 09/01/2015. MANUFACTURE DATE: 09/01/2010. AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN INVESTIGATION WAS PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERFACE ORTHOPEDIC (RIO) AND RESTORIS MCK. DURING THE PATIENT'S DIAGNOSTIC SCOPING PROCEDURE, THE SURGEON NOTED THAT THERE WERE NO SIGNS OF IMPLANT LOOSENING OR INFECTION. AS SUCH, IT WAS CONCLUDED THAT NEITHER THE RIO OR RESTORIS MCK CAUSED OR CONTRIBUTED TO THE NEED FOR THE REVISION.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED AN ONLAY BICOMPARTMENTAL PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (RESTORIS MCK) ON (B)(6) 2011. A SUBSEQUENT DIAGNOSTIC SCOPING PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT'S PERSISTENT PAIN AND STIFFNESS AFTER THE MAKO PROCEDURE WAS PERFORMED. THE SURGEON REVISED THE PATIENT TO A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 DUE TO NON-RELIEF OF PATIENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM BICOMPARTMENTAL KNEE SYSTEM NPJ MAKO SURGICAL 180507, 180607 14250310, 26110810

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention