MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTIPCOMPARTMENTAL KNEE PROSTHESIS

Model Number 180705-1

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/11/2014

Event Type  Injury  

Event Description

Due to an infection of the joint, the surgeon performed an incision and drainage procedure and exchanged the onlay insert component on (b)(6) 2014.The pt underwent partial knee arthroplasty case using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee implants on (b)(6) 2014.

Manufacturer Narrative

As part of normal complaint follow-up, an eval.Of the event has been conducted by mako surgical.

• Brand Name: RESTORIS MULTIPCOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: jonathan reeves ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280665
• MDR Report Key: 3807419
• MDR Text Key: 4523643
• Report Number: 3005985723-2014-00054
• 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: 04/11/2014

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: 05/01/2017
• Device Model Number: 180705-1
• Device Lot Number: 12260412-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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: 60 YR