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 Bone Fracture(s) (1870)

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

Mr (b)(6) had bilateral mako unicompartmental knee asthroplasty, placed, according to operative report, we make size 6 femur, size 7 tibia, 8mm polyethylene insert, pain continued after the implant.A visit to the er on (b)(6) had him sent back to his surgeon who did an x ray which showed bilateral fractures of the medical condyles by the base plates.Mr (b)(6) required extensive surgery to remove and replace the implants.

Manufacturer Narrative

(b)(4) is a duplicate.This event has been reported across patient's left and right knees, for implants and for the robot, across pi numbers (b)(4).(b)(4) to be closed as a duplicate.

Event Description

Mr (b)(6) had bilateral mako unicompartmental knee asthroplasty, placed, according to operative report, we make size 6 femur, size 7 tibia, 8mm polyethylene insert, pain continued after the implant.A visit to the er on (b)(6) had him sent back to his surgeon who did an x ray which showed bilateral fractures of the medical condyles by the base plates.Mr (b)(6) required extensive surgery to remove and replace the implants.

• 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: 8331632
• MDR Text Key: 135889117
• Report Number: 3005985723-2019-00130
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention