RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Sep 19, 2014
Report 3005985723-2014-00147 · MDR key 4173225
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalProduct problems
- Migration or Expulsion of Device
- Osseointegration Problem
- Unintended Movement
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
THE SURGEON HAD PERFORMED PARTIAL KNEE ARTHROPLASTY PROCEDURES USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS IN (B)(6) 2013. THE PATIENT PRESENTED WITH PAIN DURING A FOLLOW UP APPOINTMENT. THE SURGEON PERFORMED AN ARTHROSCOPY AND DISCOVERED THAT THE TIBIAL BASEPLATE WAS LOOSE. THE SURGEON THEN DECIDED TO PERFORM A REVISION TO A TOTAL KNEE REPLACEMENT.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS INITIATED AT MAKO SURGICAL. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN FURTHER INFORMATION IS OBTAINED.