RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Sep 23, 2014 · Event occurred Aug 28, 2014
Report 3005985723-2014-00151 · MDR key 4170257
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS IN (B)(6) 2014. A FEW WEEKS LATER, THE PT HEARD A POP IN HER KNEE AND COMPLAINED OF PAIN IN THE BACK OF HER KNEE. PT X-RAYS INDICATED THERE WAS EXCESS CEMENT POSTERIOR TO THE FEMORAL IMPLANT. THE SURGEON INDICATED THAT THERE WERE NO ISSUES WITH THE IMPLANTS. THE TIBIAL INSERT WAS REMOVED IN ORDER TO REMOVE THE EXCESS CEMENT, AND A NEW TIBIAL INSERT WAS THEN IMPLANTED.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT F/U, AN EVAL OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INFO IS OBTAINED.