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); Non Reproducible Results (4029)

Patient Problem Pain (1994)

Event Date 01/24/2019

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 surgery.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 2 of 23, revised due to pain, robot used in primary.The tibial onlay component & insert were exchanged approximately after 1 year of implantation of pka.

Manufacturer Narrative

Follow-up #1 and final report submitted to update mfr name, city & state, mfr site, date received by mfr, type of report, follow up type, device evaluated by mfr, evaluation codes,additional narrative and corrected data based on the results of investigation.Reported event: an event regarding revision 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 28 other reported events (b)(4).Conclusion: product inspection could not be performed because session files and logs were not available due to all data de-identified.

Event Description

This pi is for the robot used in the primary surgery.Information received from sales rep on 1/24/2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table attached.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 2 of 23, revised due to pain, robot used in primary.The tibial onlay component & insert were exchanged approximately after 1 year of implantation of pka.Pka.

• 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: 8331634
• MDR Text Key: 135888212
• Report Number: 3005985723-2019-00131
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR