BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST/TFS TOTAL HIP SYSTEM

    MDR report key: 3843583 · Received May 22, 2014

    Report

    Report Number
    3005985723-2014-00064
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OQG
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 DATE SUGGEST THE RIO OPERATED AS EXPECTED. THE FEMORAL STEM AND HEAD COMPONENTS CHOSEN BY THE SURGEON (DJO MICROMAX STEM, DJO HEAD) ARE NOT DESIGNED TO BE USED WITH MAKO'S RESTORIS PST ACETABULAR CUP AND THE RIO TOTAL HIP APPLICATION. THIS WAS DETERMINED TO BE THE LIKELY CAUSE OF THE EVENT.

    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. MAKO WAS INFORMED THAT THE PT EXPERIENCED A SECOND DISLOCATION ON (B)(6) 2014, AS WELL AS ONE 30 DAYS PRIOR. ON THE DATE OF THIS REPORT, A REVISION PROCEDURE WAS PERFORMED BY THE SURGEON. THE SURGEON SUSPECTED THAT THE CAUSE OF THE DISLOCATIONS WAS DUE TO IMPINGEMENT OF THE FEMORAL STEM. THE 36MM ACETABULAR LINER WAS REMOVED, AND REPLACED WITH A 40MM HIGH WALL LINER AND A 40MM FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306727 RESTORIS PST/TFS TOTAL HIP SYSTEM ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL 186136-56 190222-01

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)| DJO FEMORAL HEAD| DJO MICROMAX STEM