MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/20/2014

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 implants.The patient experienced some pain at approximately 30 days post-operatively.The pain eventually subsided.At the 90 day follow up, the surgeon noticed that the follow-up x-ray showed an anterior tibial fracture, which had healed.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been conducted by mako surgical.The anterior tibial collapse was the reason for the patient's pain.The fracture healed by the 90 day follow up visit, and the patient's pain had subsided.The surgeon reviewed the x-ray and determined that no medical intervention is required.The rio case session files were also reviewed.All values were found to be within acceptable tolerances, and the data suggest that the rio operated as expected.

• 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: 3716166
• MDR Text Key: 4233216
• Report Number: 3005985723-2014-00031
• 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: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 70 YR
• Patient Weight: 68