MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/19/2020

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 in the primary procedure. As reported in (b)(4): "doctor revised a triathlon pa beaded femoral component size 3 to a cemented size 2 primary cr femur. He also swapped the tibial insert. He did this due to patient stiffness. He said the implant wasn't grossly loose, but noted the distal and posterior interface was mostly fibrous ingrowth. He did note the original x-ray, it looked like the femur may have been flexed slightly relative to the cuts which caused a slight gap in certain areas. Right knee. " rep provided primary and revision usage sheets and reported that no further information will be released by the hospital or surgeon.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9837064
• MDR Text Key: 183772342
• Report Number: 3005985723-2020-00159
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2020
• 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 Treatment Data

Date Received: 03/16/2020 Patient Sequence Number: 1