BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8946469 · Received August 29, 2019

    Report

    Report Number
    3005985723-2019-00607
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 14, 2019
    Report Date
    March 4, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING SOFTWARE ERROR INVOLVING 3.0 RIO® ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS CONVERTED FROM A PKA TO A TKA DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR TO PAIN UNKNOWN). A MAKO PKA WAS CONVERTED TO A TRIATHLON TKA. REP PROVIDED THE PRIMARY USAGE SHEET AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.¿ PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH RIO 566 INDICATE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO SIMILAR COMPLAINTS FOR PKA SOFTWARE - OTHER. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS NO CASE SESSION DATA OR LOGS WERE PROVIDED AFTER THREE COMMUNICATION ATTEMPTS WERE MADE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED SUCH AS THE SESSION FILES, THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A SEARCH OF THE NC/CAPA DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO RECORDS RELATED TO PKA SOFTWARE.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ROBOT USED IN THE PRIMARY PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS CONVERTED FROM A PKA TO A TKA DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR TO PAIN UNKNOWN). A MAKO PKA WAS CONVERTED TO A TRIATHLON TKA. REP PROVIDED THE PRIMARY USAGE SHEET AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    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 PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS CONVERTED FROM A PKA TO A TKA DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR TO PAIN UNKNOWN). A MAKO PKA WAS CONVERTED TO A TRIATHLON TKA. REP PROVIDED THE PRIMARY USAGE SHEET AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739781 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other