MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180705-1

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 04/15/2014

Event Type  Injury  

Event Description

A pt had rec'd a partial knee arthroplasty, which was performed using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.More than six months later, the surgeon performed an arthroscopic procedure to see if soft tissues were causing a new occurrence of pain in high knee flexion.The issue was resolved, but one of the arthroscopy ports became infected.On the date of event, the surgeon performed an incision and drainage (i&d) procedure and exchanged the onlay insert component.The component was replaced with a component of the same size and thickness, and new cross linked material.

Manufacturer Narrative

As part of normal complaint f/u, an eval of the event has been initiated by mako surgical.The infection is reportedly linked to the arthroscopic procedure, and not to the mako device.At this time, there is no evidence to suggest that the rio or mck implants contributed to the infection.The eval is ongoing, and a supplemental report will be filed if add'l info is obtained.

• 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: 3836075
• MDR Text Key: 4396186
• Report Number: 3005985723-2014-00058
• 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: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• 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: 12180413-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• 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: 37 YR
• Patient Weight: 75