BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS MCK

    MDR report key: 2574503 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00088
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    March 28, 2011
    Report Date
    April 26, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP AN EVALUATION WAS INITIATED BY MAKO SURGICAL WITH REGARDS TO THE EVENT. DURING TRIALING OF THE KNEE, THE TENSION OF THE LIGAMENTS BETWEEN THE FEMUR AND TIBIA APPLIES A COMPRESSIVE FORCE TO THE TRIALS THAT CAN MAKE THE EXTRACTION OF THE ONLAY INSERT TRIAL VERY DIFFICULT USING STANDARD SURGICAL INSTRUMENTS (HEMOSTATS AND OSTEOTOMES). MAKO DID NOT ORIGINALLY PROVIDE AN INSTRUMENT FOR THE EXTRACTION OF THE TRIAL USING THE REMOVAL HOLES IN THE TRIALS. AN ONLAY INSERT EXTRACTOR TOOL HAS BEEN DESIGNED AND TESTED, AND IS CURRENTLY BEING RELEASED TO THE FIELD TO IMPROVE THE EASE OF TRIAL REMOVAL.

    Description of Event or Problem · 1

    A SURGEON TRAINED AND FAMILIAR WITH MAKOPLASTY PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) OBSERVED THAT MCK TRIAL INSERTS APPEARED TO BE DELAMINATING. NO DELAMINATED TRIALS WERE REPORTED TO HAVE BEEN OBSERVED OR USED DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MCK INSTRUMENTATION, UNICONDYLAR KNEE SYSTEM HAW MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA