BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8757382 · Received July 3, 2019

    Report

    Report Number
    3005985723-2019-00481
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 11, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 084 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO SIMILAR COMPLAINTS FOR THA SOFTWARE - CRACK/FRACTURE. CONCLUSION: NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ROBOT USED IN THE PRIMARY LEFT HIP PROCEDURE. IT WAS REPORTED THAT THE PATIENT SUFFERED BILATERAL FEMORAL FRACTURES 6 DAYS AFTER HAVING A BILATERAL HIP REPLACEMENT. THE ANATO STEMS AND BIOLOX HEADS WERE REVISED TO RESTORATION MODULAR STEM CONSTRUCTS AND BIOLOX HEADS.

    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 LEFT HIP PROCEDURE. IT WAS REPORTED THAT THE PATIENT SUFFERED BILATERAL FEMORAL FRACTURES 6 DAYS AFTER HAVING A BILATERAL HIP REPLACEMENT. THE ANATO STEMS AND BIOLOX HEADS WERE REVISED TO RESTORATION MODULAR STEM CONSTRUCTS AND BIOLOX HEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550695 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other