BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST/TFS TOTAL HIP SYS

    MDR report key: 3964139 · Received July 11, 2014

    Report

    Report Number
    3005985723-2014-00089
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OQG
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE CAUSE FOR THE REVISION IS UNK AT THIS TIME. THE EVALUATION IS CURRENTLY 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 SYS (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYS. ABOUT A MONTH AFTER SURGERY, THE SURGEON PERFORMED A REVISION OF THE STEM, TO A RESTORIS METAFIX STEM. THE SURGEON ALSO EXCHANGED THE PST ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408060 RESTORIS PST/TFS TOTAL HIP SYS ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL 186004-04 100083-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO)