MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180705-1

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/19/2014

Event Type  Injury  

Event Description

A surgeon informed mako surgical on (b)(6) 2014 that he may have to revise a pt who underwent a partial knee arthroplasty case using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee implants on (b)(6) 2014.Due to an infection of the joint, the surgeon performed an incision and drainage procedure.The surgeon performed an incision and drainage procedure and exchanged the onlay insert component.

Manufacturer Narrative

As part of normal complaint follow-up, an eval of the event has been conducted by mako surgical.The surgeon stated that the infection had nothing to do with the implants.This report is being filed in an abundance of caution to ensure compliance to the mdr regulation an dis based on the incision and drainage procedure performed to address the infection.No evidence suggests that the infection was due to any mako product.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3779149
• MDR Text Key: 4438252
• Report Number: 3005985723-2014-00039
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 180705-1
• Device Lot Number: 12040413-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR