MAUDE Adverse Event Report: MAKO SURGICAL CORP. RESTORIS MULTICOMPARTMETNAL KNEE PROSTESIS; COMPARTMENTAL KNEE PROSTHESIS

Model Number 180704-1

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/29/2014

Event Type  Injury  

Event Description

The surgeon had performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee implants.Approximately two weeks post-operatively, the pt was treated with an incision and drainage procedure.The onlay tibial insert component was also exchanged.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been conducted by mako surgical.The surgeon stated that an onlay insert exchange is routine procedure for wounds that appear inflamed after surgery.No infection was reported for the pt.At this time, no mako implant component has been known to have contributed to post-op inflammation or infection.

• Brand Name: RESTORIS MULTICOMPARTMETNAL KNEE PROSTESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3877724
• MDR Text Key: 4566672
• Report Number: 3005985723-2014-00069
• 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: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 180704-1
• Device Lot Number: 12030813-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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 SYS (RIO)
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR