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); Material Integrity Problem (2978)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/28/2018

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

Complaint against the robot: removed previously implanted tibial component ((b)(6) 2017) because of loosening.Case type: pka.Mps stated: the date of original implantation is not still on the robot.Above date is the day it was revised.No information to give as the revised surgery was not robotic.

Event Description

Complaint against the robot removed previously implanted tibial component on (b)(6) 2017) because of loosening.Case type: pka.Mps stated the date of original implantation is not still on the robot.Above date is the day it was revised.No information to give as the revised surgery was not robotic.

Manufacturer Narrative

Follow-up #1 and final report submitted to update: manufacturer name, city and state, mfr site, pma/510k, if follow-up, what type, and device evaluated by mfr based on the results of investigation.Reported event: an event regarding revision due to pain involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: product history review could not be performed because robot serial number was not received.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 11 other reported events (b)(4).Conclusion: product inspection could not be performed because session files and logs were not available.

• 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: 8196918
• MDR Text Key: 131417797
• Report Number: 3005985723-2018-00782
• 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: company representative
• 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: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• 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: 52 YR
• Patient Weight: 78