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); Output Problem (3005)

Patient Problem Discomfort (2330)

Event Date 03/27/2019

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.Patient called stating he had a right knee replacement done on (b)(6) 2018 and was revised on (b)(6) 2019 due to instability.Patient stated his surgery was done robotically, and would like to know if the robot was involved in a recall.

Manufacturer Narrative

Reported event: an event regarding revision surgery due to implant instability following a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 590 found quality inspection procedures successfully passed.-complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision surgery due to instability following a tka procedure.There were other reported events for the listed catalog number ((b)(4)).Conclusion: combined rotatory malposition of femoral and tibial component has contributed to instability in this patient¿s triathlon knee arthroplasty requiring revision surgery.Part of the problem may be explained by unknown issues encountered during instrumentation while using robotic assistance for the procedure but there is no information available to further detail these aspects.Does the review identify any procedural related factors that contributed to the event? - combined rotatory malposition of femoral and tibial component possibly as a consequence to error in use of the mako robot does the review identify any patient related factors that contributed to the event? - none does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices.

Event Description

This pi is for the robot.Patient called stating he had a right knee replacement done on (b)(6) 2018 and was revised on (b)(6) 2019 due to instability.Patient stated his surgery was done robotically, and would like to know if the robot was involved in a recall.

• 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: 8573854
• MDR Text Key: 143841531
• Report Number: 3005985723-2019-00334
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 78