RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Additional Manufacturer Narrative

AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED TO THE MAKOPLASTY PROCEDURE NOR THE MCK IMPLANTS. THE PATIENT HAS NOT YET RECEIVED THE SECOND STAGE OF THE REVISION PROCEDURE; THE ANTIBIOTIC REGIMEN IS PLANNED TO LAST APPROXIMATELY SIX WEEKS. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.

Description of Event or Problem

THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. THE PATIENT LATER COMPLAINED OF KNEE PAIN WHICH WAS DIFFERENT FROM THE PAIN EXPERIENCED BEFORE THE INITIAL SURGERY. ONCE THE SURGEON CUT INTO THE PATIENT'S KNEE, A LOT OF FLUID AND GREEN PUS WAS NOTICED COMING OUT OF THE JOINT. THE SURGEON TOOK CULTURES AND REMOVED THE FEMORAL, TIBIAL AND POLY IMPLANT COMPONENTS. THE SURGEON THEN PACKED THE JOINT WITH ANTIBIOTICS IN CEMENT AND INSERTED NEW FEMORAL AND POLY COMPONENTS. THE TIBIAL BASEPLATE WAS NOT RE-USED NOR WAS A NEW ONE IMPLANTED. A SMALLER SIZED POLY COMPONENT WAS USED AS THE PREVIOUS SIZE WAS DETERMINED TO BE TOO TIGHT. THE SURGEON INDICATED THAT HE WOULD LEAVE THE KNEE ALONE FOR 6 WEEKS THEN REVISE IT TO A TOTAL KNEE ARTHROPLASTY.