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

Catalog Number 209999

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 07/24/2013

Event Type  malfunction  

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

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.This is a (b)(6) year old male who presents with the complaint(s) of 1.5 years s/p r med uka with (b)(6) on (b)(6) 2011 at (b)(6) hospital.Was doing well until 6 mos post op, was struck by a wave at the beach and has had pain since.Pain descending stairs.A lot of pain when off celebrex.No swelling, warmth, drainage.

Manufacturer Narrative

An mdr for catalog 209999 should not have been submitted because the patient experienced pain after the incident occurred where he was struck by a wave.

Event Description

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.This is a (b)(6) male who presents with the complaint(s) of 1.5 years s/p r med uka with rob on (b)(6) 2011 at (b)(6).Was doing well until 6 mos post op, was struck by a wave at the beach and has had pain since.Pain descending stairs.A lot of pain when off celebrex.No swelling, warmth, drainage.

• 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6424871
• MDR Text Key: 70640801
• Report Number: 3005985723-2017-00137
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 93