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); Non Reproducible Results (4029)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 01/30/2019

Event Type  malfunction  

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 the robot used in the primary procedure. It was reported that the patient's left hip was revised due to femoral periprosthetic fracture (possible cause or contributor for fracture not reported to the rep). An accolade ii stem, 40 +12 metal head, and 40f 0° liner were revised to an mdm/adm liner construct with competitor stem and head. Rep provided a pre-revision x-ray and reported that additional x-rays, medical records, and additional information are not available due to hospital policy.

• 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: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 8351652
• MDR Text Key: 136614124
• Report Number: 3005985723-2019-00149
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 03/28/2019
• 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: 02/19/2019 Patient Sequence Number: 1