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

Catalog Number 209999

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

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

Partial lateral menisectomy.Scheduled for revision to tka on (b)(6) 2016 due to progression of arthritis in the lateral compartment of the left knee.

Manufacturer Narrative

Reported event: an event regarding a pka revision involving a 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: not performed as the device being inspected is software.Rio serial number not reported.Complaint history: based on the device identification (pn (b)(4)) the complaint databases were reviewed from 2011 to present for similar reported events regarding patient revision from pka to tka.There were five other reported events for the listed catalog number.((b)(4)) conclusion: device inspection could not be performed, no session data was provided.Device not returned.

Event Description

Partial lateral menisectomy.Scheduled for revision to tka on (b)(6) 2016 due to progression of arthritis in the lateral compartment of the left knee.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTACTIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6309747
• MDR Text Key: 66760670
• Report Number: 3005985723-2017-00057
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other