BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST TOTAL HIP SYSTEM

    MDR report key: 3760803 · Received April 3, 2014

    Report

    Report Number
    3005985723-2014-00034
    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
    PA, 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. FOUR POSSIBLE CAUSES TO THIS ISSUE HAVE BEEN IDENTIFIED: UNINTENTIONAL ARRAY MOVEMENT (BETWEEN BONE REGISTRATION AND REAMING/IMPACTION); POST-OPERATIVE MOVEMENT OF CUP; SUB-OPTIMAL PELVIC REGISTRATION; UNSTABLE POSITIONING OF RIO PLATFORM. AT THIS TIME, CURRENTLY AVAILABLE DATA ONLY SUPPORTS ARRAY MOVEMENT AS BEING THE ROOT CAUSE HOWEVER THE POSSIBILITY EXISTS THAT THE OTHER CAUSES MAY HAVE ALSO CONTRIBUTED TO THIS ISSUE.

    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. THE ORIGINAL SURGICAL PLAN HAD CUP AT 41 DEGREES INCLINATION. THE IMPACTION NUMBERS ON THE RIO WERE THE SAME AS THE SURGICAL PLAN. THE SURGEON EVALUATED THE CUP PLACEMENT IN THE POST-OPERATIVE X-RAY AND MEASURED A VALUE OF 63 DEGREES INCLINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200661 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)