BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

    MDR report key: 3251790 · Received July 18, 2013

    Report

    Report Number
    3005985723-2013-00048
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K093425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION HAS BEEN PERFORMED WITH REGARD TO THIS EVENT. THE PATIENT'S INFECTION WAS STATED TO HAVE ORIGINATED FROM AN ADDITIONAL SURGERY, UNRELATED TO THE MAKOPLASTY THA. MAKO DISPOSABLES UNDERGO A VALIDATED GAMMA STERILIZATION PROCESS BEFORE USE, ARE LABELED FOR SINGLE USE ONLY, AND ARE TESTED FOR ABILITY TO WITHSTAND EXTREME ENVIRONMENTAL AND DISTRIBUTION CONDITIONS. MAKO REUSABLE INSTRUMENT DESIGNS ARE VERIFIED FOR ABILITY TO BE DISINFECTED AND STERILIZED BETWEEN PROCEDURES. VALIDATED DISINFECTION AND STERILIZATION PROCEDURES ARE PROVIDED FOR CUSTOMERS IN 203855 REV 06 MAKOPLASTY TOTAL HIP APPLICATION INSTRUMENT CLEANING AND STERILIZATION GUIDE. THE RIO STERILE DRAPING PROCEDURE VALIDATION IS DOCUMENTED AND TRAINING IS PROVIDED TO HOSPITAL PERSONNEL ON DRAPING PROCEDURE. OTHER STERILE PROCEDURES ARE CONTROLLED BY HOSPITAL STAFF, AND ARE NOT DOCUMENTED IN MAKO PROTOCOLS OR USER PROCEDURES. AT THIS TIME, THERE IS NO EVIDENCE THAT THE INFECTION WAS CAUSED BY ANY MAKO COMPONENTS NOR DUE TO THE MAKOPLASTY PROCEDURE, AS DOCUMENTED.

    Description of Event or Problem · 1

    ABOUT THREE WEEKS AFTER PERFORMING A PRIMARY TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE SURGEON SWAPPED OUT THE PATIENT'S ACETABULAR LINEAR COMPONENT FOR A NEW ONE DUE TO AN INFECTION FROM A PERVIOUS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335342 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA STEREOTAXIC INSTRUMENT, ACCESSORY OLO MAKO SURGICAL 203999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PIPELINE ORTHOPEDICS TOTAL HIP PROSTHESIS