BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERSTORIS PST/TFS TOTAL HIP SYSTEM

    MDR report key: 3833380 · Received May 16, 2014

    Report

    Report Number
    3005985723-2014-00060
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OQG
    PMA / PMN Number
    K112802
    Adverse Event
    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 OF THE EVENT WAS INITIATED AT MAKO SURGICAL. THE RIO SESSION FILES WERE REVIEWED. ALL VALUES WERE FOUND TO BE WITHIN ACCEPTABLE TOLERANCES. THE DATA SUGGEST THE RIO OPERATED AS EXPECTED. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYSTEM ON (B)(4) 2014. MAKO WAS INFORMED THAT THE PATIENT EXPERIENCED A FEMORAL FRACTURE APPROXIMATELY A WEEK AND A HALF POST-OPERATIVELY. THE SURGEON PERFORMED A REVISION PROCEDURE, REMOVING THE FEMORAL COMPONENTS AND VERIFYING THE INTEGRITY AND PLACEMENT OF THE ACETABULAR CUP. THE SURGEON OPTED TO PLACE TWO ACETABULAR BONE SCREWS AND REPLACE THE ACETABULAR LINER WITH AN IDENTICAL COMPONENT. THE FRACTURE WAS TREATED WITH CIRCLAGE WIRE, AND A REVISION STEM WAS IMPLANTED, ALONG WITH A REPLACEMENT FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293379 ERSTORIS PST/TFS TOTAL HIP SYSTEM ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL 186004-06 100010-01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)