BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8064723 · Received November 13, 2018

    Report

    Report Number
    3005985723-2018-00671
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 5, 2018
    Report Date
    April 15, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING A REVISION INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: -DEVICE HISTORY REVIEW: NOT PERFORMED AS THE DEVICE BEING INSPECTED IS SOFTWARE. RIO SERIAL NUMBER NOT REPORTED. -COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING A REVISION FROM A PARTIAL KNEE PROCEDURE TO A TOTAL KNEE PROCEDURE DUE TO PAIN. THERE WERE 10 OTHER REPORTED EVENTS ( PR 1623865, PR 1623940, PR1638056, PR1691636, PR1728493, PR1893969, PR1915354, PR1915371, PR1928578, AND PR1921712). CONCLUSION: NO INVESTIGATION WAS CONDUCTED DUE TO FURTHER INFOMRATION NOT BEING AVAILABLE BECAUSE OF HOSPITAL POLICY.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ROBOT. AS REPORTED IN PI 1940347: IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO LOOSENING AFTER PATIENT COMPLAINT OF PAIN. UPDATE 12/NOVEMBER/2018 SPOKE TO REP. THE FEMORAL COMPONENT WAS SLIGHTLY LOOSE. THE TIBIAL COMPONENT AND SPACER WERE WELL-FIXED AD WELL-POSITIONED. REP PROVIDED PRIMARY AND REVISION IMPLANT SHEETS AND REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

    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 PI IS FOR THE ROBOT. AS REPORTED IN (B)(4): IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO LOOSENING AFTER PATIENT COMPLAINT OF PAIN. UPDATE (B)(6) 2018 SPOKE TO REP. THE FEMORAL COMPONENT WAS SLIGHTLY LOOSE. THE TIBIAL COMPONENT AND SPACER WERE WELL-FIXED AD WELL-POSITIONED. REP PROVIDED PRIMARY AND REVISION IMPLANT SHEETS AND REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907146 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R