MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180704-2

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Post Operative Wound Infection (2446)

Event Date 05/10/2014

Event Type  Injury  

Event Description

A patient had received a partial knee arthroplasty, which was performed using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants on (b)(6) 2014.Almost a month later, the patient was reportedly walking without support, and fractured the tibia.The wound was also infected, so the patient was treated at a different hospital, and an exchange of the onlay tibial insert component was performed.

Manufacturer Narrative

An evaluation of this event is currently underway at mako surgical.The patient's activity was reportedly non-compliant with the doctor's recommendations.The issues experienced by the patient are reportedly not attributed to the rio or the implants.An onlay tibial insert, or poly, exchange is a common and routine practice following infection of the knee joint with arthroplasty components as a preventative measure to ensure that no infectious organisms are present on the poly after the joint is washed out.

• 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., suite 110; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3877872
• MDR Text Key: 4570938
• Report Number: 3005985723-2014-00073
• 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: 05/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 180704-2
• Device Lot Number: 12010213-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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: 57 YR