BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2634262 · Received June 21, 2012

    Report

    Report Number
    3005985723-2012-00174
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    January 5, 2012
    Report Date
    May 25, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL #: 180607, LOT #: 26110810, EXPIRATION DATE: 09/2015. AS PART OF NORMAL COMPLAINT F/U, AN INVESTIGATION WAS PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE RIO AND RESTORIS MCK. THE SURGEON STATED THAT THE REVISION TO TKA WAS DUE TO THE PT'S PERSISTENT PAIN AFTER THE ORIGINAL PROCEDURE. THE SURGEON ALSO STATED THAT DURING THE REVISION PROCEDURE, HE DID NOT OBSERVE ANY REASON TO IMPLY THAT THE MAKO PRODUCTS USED IN THE ORIGINAL PROCEDURE CAUSED OR CONTRIBUTED TO THE NEED FOR THE REVISION TO TKA.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (RESTORIS MCK) ON (B)(6) 2011. MAKO SURGICAL WAS MADE AWARE ON MAY 25, 2012 THAT THE PT WAS REVISED TO A TOTAL KNEE ARTHROPLASTY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM UNICONDYLAR KNEE NPJ MAKO SURGICAL 180707-1 12091010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention