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

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

As part of the 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 patient 3 of 3. (b)(6) y/o male, surgery (b)(6) 2019. Right knee. As reported by surgeon: attached are xrays of three patients i previously discussed. All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op. Thus far, none have required revision but all have some degree of pain (mostly medial). Again i never saw this prior the mics transition. Let me know your thoughts and if any other surgeons have seen this issue. More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better. Case type: pka 3. 0.

• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9780243
• MDR Text Key: 181780879
• Report Number: 3005985723-2020-00130
• 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,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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

Device Operator

• Device Model Number: 209999
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• 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: 06/23/2020
• 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: 03/03/2020 Patient Sequence Number: 1