RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Description of Event or Problem

THE PATIENT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROXIMATELY FIVE MONTHS LATER, THE PATIENT RECEIVED MED TREATMENT BECAUSE THE INSIDE LAYER OF SUTURES HAD PULLED OUT. THE SURGEON TOOK CULTURES, AND THEN EXCHANGED THE ONLY INSERT COMPONENT AS A PRECAUTION. CULTURES WERE NEGATIVE FOR INFECTION. THE WOUND WAS CLOSED, AND THE PATIENT RETURNED TO NORMAL ACTIVITIES. ABOUT TWO WEEKS LATER, THE PATIENT PRESENTED WITH AN INFECTED KNEE. THE SURGEON CHOSE TO REMOVE THE MCK IMPLANT COMPONENTS AND PERFORM A TWO-STAGE REVISION PROCEDURE (REMOVE IMPLANTS AND IMMOBILIZE THE JOINT WHILE UNDERGOING ANTIBIOTIC TREATMENT, AND FOLLOW WITH A TOTAL KNEE PROCEDURE WHEN THE INFECTION HAS CLEARED). USING A NEW MCK FEMORAL COMPONENT, THE SURGEON CREATED A CEMENT SPACER BY COVERING THE COMPONENT WITH CEMENT AND IMPLANTING THE COMPONENT. THE PATIENT WILL FOLLOW AN ANTIBIOTIC REGIMEN, AND THEN THE SURGEON WILL PROCEED WITH THE SECOND STAGE OF THE REVISION.

Additional Manufacturer Narrative

AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVAL OF THE EVEN 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 THE LAST APPROXIMATELY SIX WEEKS, OR UNTIL THE INFECTION IS CLEARED. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.