BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PTS/TFS TOTAL HIP SYSTEM

    MDR report key: 3918840 · Received June 25, 2014

    Report

    Report Number
    3005985723-2014-00083
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MAKO SURGICAL
    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 EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE SURGEON REVISED THE PATIENT'S CUP AND LINER COMPONENTS TO THE STRYKER MDM CUP AND LINER SYSTEM, WHICH IS INDICATED FOR PATIENTS PRONE TO DISLOCATION. THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST THAT THE RIO OR PST/TFS IMPLANT SYSTEMS CONTRIBUTED TO THE EVENT. HOWEVER, FURTHER EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYSTEM. MORE THAN A YEAR AFTER THE ORIGINAL SURGERY, THE SURGEON PERFORMED A REVISION PROCEDURE. THE PATIENT HAD COMPLAINED OF PAIN, AND HAD DISLOCATED THE JOINT TWICE. DURING THE REVISION PROCEDURE, THE SURGEON STATED THAT IMPLANT PLACEMENT WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369707 RESTORIS PTS/TFS TOTAL HIP SYSTEM ARTIFICIAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL

    Patients

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