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

Catalog Number 209999

Device Problem Computer Software Problem (1112)

Patient Problem Pain (1994)

Event Date 12/10/2018

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 navigation of the primary.As reported in pi (b)(4): "it was reported that the patient's right knee was revised to pain (surgeon reported the existence of patellofemoral arthritis, which could have been a possible cause/ contributor to pain.There were no allegations against the in situ implants).A mako uni tibia, poly insert, and femoral component were revised.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy".

Manufacturer Narrative

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 12 other reported events ( pr 1623865, pr 1623940, pr1638056, pr1691636, pr1728493, pr1893969, pr1915354, pr1915371, pr1928578, pr1921712, pr1956944, and pr1968316).Conclusion: product inspection could not be performed because session files and logs were not available due to hospital policy.

Event Description

This pi is for the robot used in navigation of the primary.As reported in pi (b)(4): "it was reported that the patient's right knee was revised to pain (surgeon reported the existence of patellofemoral arthritis, which could have been a possible cause/ contributor to pain.There were no allegations against the in situ implants).A mako uni tibia, poly insert, and femoral component were revised.Rep reported that x-rays, medical records, and additional information are not 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: 8202685
• MDR Text Key: 131611223
• Report Number: 3005985723-2018-00790
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 128