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 10/01/2018

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 during the primary.It was reported that patient's knee was revised.Patient was revised to a triathlon ts knee construct.

Event Description

This pi is for the robot used during the primary.It was reported that patient's knee was revised.Patient was revised to a triathlon ts knee construct.

Manufacturer Narrative

Reported event: an event regarding revision due to pain involving 3.0 rio robotic arm - mics, catalog: (b)(4).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 (b)(4) 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 6 other reported events (b)(4).-conclusion: product inspection could not be performed because session files and logs were not received after 3 communications to mps.

• 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: 7973589
• MDR Text Key: 123961117
• Report Number: 3005985723-2018-00605
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 64