BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8485713 · Received April 4, 2019

    Report

    Report Number
    3005985723-2019-00279
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 23, 2019
    Report Date
    June 17, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING REVISION INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: -DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 293 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 REVISION. THERE WERE 8 OTHER REPORTED EVENT FOR THE LISTED CATALOG NUMBER (PR1442085, PR1737869, PR1898251, PR1930169, PR1950907, PR1962866, PR2008297, AND PR2028445). -CONCLUSION: PRODUCT INSPECTION COULD NOT BE COMPLETED DUE TO NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ROBOT USED IN THE PRIMARY SURGERY. IN PROVIDING DOCUMENTATION FOR A REVISION OF PATIENT'S RIGHT HIP ON (B)(6) 2019 (PI 2041927), REP PROVIDED AN OPERATIVE REPORT FROM A REVISION ON (B)(6) 2018. THE OPERATIVE REPORT INDICATES PREOPERATIVE DIAGNOSIS OF "ASEPTIC LOOSENING, ACETABULAR COMPONENT, RIGHT TOTAL HIP ARTHROPLASTY". PROCEDURE NOTES INDICATE "...THERE WAS A BULBOUS AREA OF BLOOD-TINGED, BROWNISH FLUID DISTENDING THE JOINT...WE REMOVED THE CUP, WHICH WAS GROSSLY LOOSE...THIS WAS DONE AFTER FIRST REMOVING THE 3 DOME SCREWS FROM THE HEMISPHERICAL TRIDENT CUP. THE SCREWS HAD VERY LITTLE FIXATION...THERE WAS MINIMAL TO NO BONE LOSS. HOWEVER, UPON REAMING, IT WAS APPARENT THAT THERE WAS NOT A TON OF BONE IN HER POSTERIOR COLUMN...". REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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 PI IS FOR THE ROBOT USED IN THE PRIMARY SURGERY. IN PROVIDING DOCUMENTATION FOR A REVISION OF PATIENT'S RIGHT HIP ON (B)(6) 2019 ((B)(4)), REP PROVIDED AN OPERATIVE REPORT FROM A REVISION ON SEPTEMBER 4, 2018. THE OPERATIVE REPORT INDICATES PREOPERATIVE DIAGNOSIS OF "ASEPTIC LOOSENING, ACETABULAR COMPONENT, RIGHT TOTAL HIP ARTHROPLASTY". PROCEDURE NOTES INDICATE "...THERE WAS A BULBOUS AREA OF BLOOD-TINGED, BROWNISH FLUID DISTENDING THE JOINT...WE REMOVED THE CUP, WHICH WAS GROSSLY LOOSE...THIS WAS DONE AFTER FIRST REMOVING THE 3 DOME SCREWS FROM THE HEMISPHERICAL TRIDENT CUP. THE SCREWS HAD VERY LITTLE FIXATION...THERE WAS MINIMAL TO NO BONE LOSS. HOWEVER, UPON REAMING, IT WAS APPARENT THAT THERE WAS NOT A TON OF BONE IN HER POSTERIOR COLUMN...". REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274443 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention