BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST/TFS TOTAL HIP SYSTEM

    MDR report key: 3843590 · Received May 22, 2014

    Report

    Report Number
    3005985723-2014-00063
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PT REPORTEDLY FELT UNSTABLE AND WAS ABLE TO POP THE JOINT IN AND OUT, BUT THEN FULLY DISLOCATED BEFORE NEEDING TO BE REDUCED. THE SURGEON STATED THAT THE CUP PLACEMENT LOOKS GREAT AND THAT A POSSIBLE SOLUTION WILL BE LENGTHEN THE FEMORAL HEAD COMPONENT. CURRENTLY, THE PRESCRIBED TREATMENT IS FOR THE PT TO BE IMMOBILIZED FOR ONE MONTH. EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ADDITIONAL INFO IS 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, MAKO WAS INFORMED THAT THE PT EXPERIENCED A DISLOCATION, AND HAD TO UNDERGO A CLOSED REDUCTION PERFORMED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306720 RESTORIS PST/TFS TOTAL HIP SYSTEM ARTIFICIAL TOTAL HIP REPLACEMENT OLO MAKO SURGICAL CORP.

    Patients

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