BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 7315903 · Received March 6, 2018

    Report

    Report Number
    3005985723-2018-00124
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 5, 2018
    Report Date
    May 3, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 152 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. -COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN (B)(4) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING CUP PLACEMENT DISCREPANCY. THERE WERE 12 OTHER REPORTED EVENTS (PR1044925, 1219418, 1233394, 1260347, 1260393, 1260426, 1260427, 1260480, 1325106, 1354370, 1600374 AND 1632449). -CONCLUSION: PLANNED AND INTRA-OPERATIVE CUP INCLINATION AND VERSION VALUES DURING IMPACTION WERE CONFIRMED IN THE SESSION FILE. AN ANALYSIS OF THE POST-OPERATIVE X-RAY SHOWS THAT THE FINAL CUP PLACEMENT IS IN CONSIDERABLY LESS INCLINATION THAN THAT REPORTED BY THE SYSTEM DURING IMPACTION. A REVIEW OF THE ACETABULAR REGISTRATION SHOWS THAT AN INACCURATE CAPTURE ON THE INITIAL REGISTRATION POINTS WHICH TRIGGERED A WARNING REGARDING REGISTRATION UNCERTAINTY. BASED ON THIS ANALYSIS, SUBOPTIMAL REPLICATION ON INITIAL LANDMARKS DURING PELVIC REGISTRATION IS THE LIKELY ROOT CAUSE FOR THE DISCREPANCY BETWEEN INTRA-OP AND POST-OP REPORTED CUP POSITIONS.

    Description of Event or Problem · 0

    ON A SURGERY DAY 2-5-18 WITH 2 TOTAL HIPS AND 1 TOTAL KNEE THROUGHOUT DAY THE MAKO SYSTEM SEEMED TO PERFORM FINE. HOWEVER THE DAY AFTER SURGERY ON 2-6-18 DR. CONNORS CALLED ME AND SAID THAT HE LOOKED AT THE POST OP FILMS AND THE CUP IN BOTH OF THE HIPS DONE THAT DAY LOOKED OFF. THE TARGET INCLINATION WAS 40 DEGREES.HE SAID THE X-RAYS LOOKED LIKE THE CUPS WERE IN 10 DEGREES OF INCLINATION. THIS PR WAS GENERATED FOR THA CASE #1. THE FILES HAVE BEEN LOADED TO THE COMPLAINTS SHARED DRIVE COMPLAINTS\2-5-18 BAYFRONT PORT CHARLOTTE DR. CONNORS.

    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

    ON A SURGERY DAY (B)(6) 2018 WITH 2 TOTAL HIPS AND 1 TOTAL KNEE THROUGHOUT DAY THE MAKO SYSTEM SEEMED TO PERFORM FINE. HOWEVER THE DAY AFTER SURGERY ON (B)(6) 2018 DR. (B)(6) CALLED ME AND SAID THAT HE LOOKED AT THE POST OP FILMS AND THE CUP IN BOTH OF THE HIPS DONE THAT DAY LOOKED OFF. THE TARGET INCLINATION WAS 40 DEGREES. SAID THE X-RAYS LOOKED LIKE THE CUPS WERE IN 10 DEGREES OF INCLINATION. THIS PR WAS GENERATED FOR THA CASE #1. THE FILES HAVE BEEN LOADED TO THE COMPLAINTS SHARED DRIVE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161793 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization