BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2582549 · Received May 18, 2012

    Report

    Report Number
    3005985723-2012-00156
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP AN EVALUATION WAS PERFORMED BY MAKO SURGICAL WITH REGARDS TO THE RIO AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM. THE SURGEON STATED THE FRACTURE OCCURRED DUE TO THE PATIENT'S LARGE SIZE AND NON-COMPLIANCE WITH RECOMMENDED POST-OPERATIVE ACTIVITIES, AND DID NOT BELIEVE MAKO PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE THAT THE RIO OR IMPLANT SYSTEM CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) IN (B)(6). A LATER REVISION PROCEDURE WAS PERFORMED DUE TO A VERTICAL TIBIAL FRACTURE UNDER THE TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 18060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention