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

Catalog Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2012

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

The surgeon completed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.Dx tibial loosening, luka, possible occult infection.Positive bone scan, slight elevation of white cell count in joint aspirate.Revision of left tka.

Manufacturer Narrative

Reported event: an event regarding a pka revision involving a 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method and 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 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding patient revision from pka to tka.There were eight other reported events for the listed catalog number.(b)(4).Conclusion: device inspection could not be performed as no session data was available.Per the mps, "robot (b)(4) was upgraded to accommodate the tka software application on (b)(6) 2016 and needed a new hard drive.The old hard drive is still at the hospital but not plugged into the machine and i have no way to access any information on it.Robot (b)(4) was removed from the hospital altogether and a different robot replaced it (b)(4) to accommodate a hardware upgrade that was required to run the robotic tka software.The device was not returned to the manufacturer.

Event Description

The surgeon completed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.Dx tibial loosening, l uka, possible occult infection.Positive bone scan, slight elevation of white cell count in joint aspirate.Revision of left tka.

• 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
• 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: 6424869
• MDR Text Key: 70579922
• Report Number: 3005985723-2017-00135
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• 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
• Patient Age: 81 YR
• Patient Weight: 90