BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PTS/TFS TOTAL HIP SYSTEM

    MDR report key: 3925599 · Received June 27, 2014

    Report

    Report Number
    3005985723-2014-00085
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OQG
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVAL OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE EVAL IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYSTEM. APPROX TWO MONTHS LATER, THE PT EXPERIENCED JOINT DISLOCATION. THEREFORE, THE SURGEON PERFORMED A REVISION PROCEDURE AND REPLACED THE 54 MM ACETABULAR CUP WITH A 60 MM CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376910 RESTORIS PTS/TFS TOTAL HIP SYSTEM ARTIFICAIL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ROBOTIC ARM INTERAVTICE ORTHOPEDIC SYSTEM (RIO)