BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST TOTAL HIP SYSTEM

    MDR report key: 3760805 · Received April 3, 2014

    Report

    Report Number
    3005985723-2014-00035
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    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 EVAL OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. THE SURGEON HAS DECIDED NOT TO REVISE THE PATIENT AT THIS TIME AND TO LET THE FRACTURE SELF HEAL. THE CASE SESSION FILES FROM THE RIO USED IN THE ORIGINAL PROCEDURE WERE REVIEWED. ALL VALUES WERE FOUND TO BE WITHIN ACCEPTABLE TOLERANCES AND IT WAS CONCLUDED THAT THE RIO OPERATED AS INTENDED. THIS ISSUE WAS THEREFORE DETERMINED TO BE THE RESULT OF THE PATIENT FALL WHICH LED TO THE CALCAR FRACTURE.

    Description of Event or Problem · 1

    A PATIENT HAD RECEIVED A TOTAL HIP ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS PST TOTAL HIP IMPLANTS. APPROX TWO TO THREE WEEKS POST-OPERATIVELY, THE PATIENT FELL AND FRACTURED THEIR CALCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200656 RESTORIS PST TOTAL HIP SYSTEM ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)