BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 7409599 · Received April 9, 2018

    Report

    Report Number
    3005985723-2018-00233
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 28, 2018
    Report Date
    July 17, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING INACCURATE CUP VERSION INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 594 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING CUP PLACEMENT DISCREPANCY. THERE WERE 13 OTHER REPORTED EVENTS (PR1044925, 1219418, 1233394, 1260347, 1260393, 1260426, 1260427, 1260480, 1325106, 1354370, 1600374, 1632449 AND 1727171). CONCLUSION: THE CUP VERSION WAS REPORTED BY THE SYSTEM AS 25 DEG BUT ACCORDING TO THE SURGEON, THE VERSION IS 50 DEG BASED ON THE X-RAY MEASUREMENT HOWEVER THE X-RAY WAS NOT PROVIDED BY THE SURGEON. A ROTATIONAL ERROR WAS OBSERVED IN THE PELVIC REGISTRATION DUE TO INACCURATE LANDMARK PICKED, AND A POTENTIAL ARRAY BUMPED WAS OBSERVED IN THE REDUCTION RESULTS PAGE.

    Description of Event or Problem · 0

    THE SURGEON BROUGHT TO OUR ATTENTION THAT ONE OF HIS THA CASES HAD DISLOCATED. THE ROBOT SAYS WE IMPLANTED THE CUP AT 25 DEGREES OF VERSION AND THE SURGEON SAYS HE MEASURES 50 DEGREES OF VERSION ON THE POST-OPERATIVE X-RAY. POSTOPERATIVELY THE SURGEON HAD A PATIENT DISLOCATE. HE SAYS HE MEASURED THE POST-OPERATIVE FILMS AND SAID THE CUP WAS PUT IN ABOUT 50 DEGREES OF VERSION INSTEAD OF THE DESIRED 25 DEGREES OF VERSION. (B)(4) IS GOING TO RETRIEVE THE LOG FILES FOR THAT PARTICULAR DATE OF (B)(6) 2017 WHEN THE CASE TOOK PLACE. THE SESSION FILES FOR THE CASE IN QUESTION ARE SHARED IN THE SHARED COMPLAINT FOLDER UNDER (B)(6) HOSPITAL.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON BROUGHT TO OUR ATTENTION THAT ONE OF HIS THA CASES HAD DISLOCATED. THE ROBOT SAYS WE IMPLANTED THE CUP AT 25 DEGREES OF VERSION AND THE SURGEON SAYS HE MEASURES 50 DEGREES OF VERSION ON THE POST-OPERATIVE X-RAY. POSTOPERATIVELY THE SURGEON HAD A PATIENT DISLOCATE. HE SAYS HE MEASURED THE POST-OPERATIVE FILMS AND SAID THE CUP WAS PUT IN ABOUT 50 DEGREES OF VERSION INSTEAD OF THE DESIRED 25 DEGREES OF VERSION. (B)(6) IS GOING TO RETRIEVE THE LOG FILES FOR THAT PARTICULAR DATE OF (B)(6) 2017 WHEN THE CASE TOOK PLACE. THE SESSION FILES FOR THE CASE IN QUESTION ARE SHARED IN THE SHARED COMPLAINT FOLDER UNDER (B)(6) 2018 WADDELL COMPLAINT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253152 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other