MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Computer Software Problem (1112); Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2018

Event Type  Injury  

Manufacturer Narrative

¿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.¿.

Event Description

This pi is for the robot used in the primary procedure.As reported in (b)(4): "dr.(b)(6) revised a total hip originally done on (b)(6) 2018 with robotic navigation, due to femur fracture.She explanted the stem and head and replaced with cone/conical, a new head and cables.Update 04/dec/2018: rep provided usage sheets for primary and revision surgeries and an x-ray and reported that no further information is available due to hospital policy.".

Manufacturer Narrative

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 four other reported event for the listed catalog number (pr1442085, pr1737869, 1898251, and 1930169).Conclusion: product inspection could not be completed due to no logs or session files not being available from hospital or surgeon.

Event Description

This pi is for the robot used in the primary procedure.As reported in pi 1955696: "dr.Sidney migliori revised a total hip originally done on (b)(6)2018 with robotic navigation, due to femur fracture.She explanted the stem and head and replaced with cone/conical, a new head and cables.Update 04/dec/2018: rep provided usage sheets for primary and revision surgeries and an x-ray and reported that no further information is available due to hospital policy.".

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8200166
• MDR Text Key: 131526649
• Report Number: 3005985723-2018-00784
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR