BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST/TFS TOTAL HIP SYS

    MDR report key: 3964134 · Received July 11, 2014

    Report

    Report Number
    3005985723-2014-00092
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 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 HAS BEEN INITIATED AT MAKO SURGICAL. THE CAUSE FOR THE INITIAL DISLOCATION IS UNK AT THIS TIME. THE EVALUATION 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 SYS (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYS. APPROXIMATELY TWO AND A HALF WEEKS LATER, THE PT DISLOCATED, AND WAS TREATED BY THE SURGEON ON CALL WITH A CLOSED REDUCTION. FOUR DAYS LATER, THE PT AGAIN DISLOCATED THE JOINT. A THIRD SURGEON AT THE SITE DETERMINED THAT THE PT'S JOINT WAS LOOSE, AND WOULD REQUIRE A REVISION. THE SURGEON REVISED THE ACETABULAR LINER TO A HIGH WALL LINER AND INCREASED THE FEMORAL HEAD LENGTH FROM 0 TO 10.5M. AFTER THE REVISION PROCEDURE, THE SURGEON STATED THAT THE PT'S HIP FELT VERY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407589 RESTORIS PST/TFS TOTAL HIP SYS ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL 186140-58 190341-01

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO)