BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 7264737 · Received February 12, 2018

    Report

    Report Number
    3005985723-2018-00069
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 20, 2018
    Report Date
    May 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
    WI, 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 111 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: BASED ON THE ANALYSIS, THERE IS A ROTATIONAL ERROR FROM PELVIC REGISTRATION DUE TO THE INACCURATE PICK OF THE ANTERIOR AND POSTERIOR LANDMARKS, WHICH CAUSE THE CUP ORIENTATION ISSUE DURING CUP IMPACTION. THE POST-OP X-RAY ANALYSIS ALSO CONFIRMED THE DISCREPANCY BETWEEN WHAT SYSTEM REPORTED AND THE ACTUAL RESULTS.

    Description of Event or Problem · 0

    THIS PATIENT ENDED UP HAVING CUP POSITIONING OF 59 DEG ABDUCTION AND 44 DEG ANTIVERSION. HERE ARE THE SCREEN SHOTS. AS YOU CAN SEE THE ACTUAL POSITION FROM THE RIO IS 39/29. THA CASE . LOGS IN THE COMPLAINTS FOLDER: COMPLAINTS: (B)(4).

    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

    THIS PATIENT ENDED UP HAVING CUP POSITIONING OF 59 DEG ABDUCTION AND 44 DEG ANTIVERSION. HERE ARE THE SCREEN SHOTS. AS YOU CAN SEE THE ACTUAL POSITION FROM THE RIO IS 39/29. THA CASE . LOGS IN THE COMPLAINTS FOLDER: COMPLAINTS\WI 355 1.30.18 ILLGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109102 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization