BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8239731 · Received January 11, 2019

    Report

    Report Number
    3005985723-2019-00044
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    December 29, 2018
    Report Date
    April 18, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING REVISION DUE TO LOOSENED IMPLANT INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 163 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 REVISION. THERE WERE 6 OTHER REPORTED EVENT FOR THE LISTED CATALOG NUMBER (PR1442085, PR1737869, PR1898251, PR1930169, PR1950907, AND PR1962866). CONCLUSION: PRODUCT INSPECTION COULD NOT BE COMPLETED DUE TO NO LOGS OR SESSION FILES NOT BEING AVAILABLE DUE TO HOSPITAL POLICY.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ROBOT USED IN THE PRIMARY PROCEDURE. IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A RESTORATION MODULAR STEM CONSTRUCT, 32 +8 LFIT V40 HEAD, AND 3 DALL-MILES CABLE AND SLEEVE SETS WERE IMPLANTED. SPOKE TO REP. PATIENT FELL AND SUSTAINED A FEMORAL PERIPROSTHETIC FRACTURE. AN ANATO STEM AND STRYKER HEAD WERE REVISED. REP 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 USED IN THE PRIMARY PROCEDURE. IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A RESTORATION MODULAR STEM CONSTRUCT, 32 +8 LFIT V40 HEAD, AND 3 DALL-MILES CABLE AND SLEEVE SETS WERE IMPLANTED. SPOKE TO REP. PATIENT FELL AND SUSTAINED A FEMORAL PERIPROSTHETIC FRACTURE. AN ANATO STEM AND STRYKER HEAD WERE REVISED. REP 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
    33459 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R