BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST/TFS TOTAL HIP SYSTEM

    MDR report key: 3787037 · Received April 25, 2014

    Report

    Report Number
    3005985723-2014-00047
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 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 WAS INITIATED AT MAKO SURGICAL. THE DISLOCATION WAS CONFIRMED VIA X-RAY. THE SURGEON PERFORMED A CLOSED REDUCTION, NOT A REVISION, AND SENT THE PT HOME WITH A BRACE. THE INVESTIGATION IS CURRENTLY ONGOING, AND ANY ADD'L INFO WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A SUCCESSFUL MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYSTEM. ON THE DATE OF THE EVENT, THE SURGEON PERFORMED A CLOSED REDUCTION ON THE PATIENT DUE TO AN ANTERIOR DISLOCATION OF THE HIP. THE PATIENT DISLOCATED WHILE BENDING DOWN WITH THE JOINT EXTERNALLY ROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250466 RESTORIS PST/TFS TOTAL HIP SYSTEM ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL CORP. 186632-01 002004-01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)