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. APPROX ONE MONTH LATE, THE PATIENT PRESENTED WITH AN INFECTED WOUND SITE. THE SURGEON PERFORMED AN INCISION AND DRAINAGE PROCEDURE, AND EXCHANGED THE TIBIAL ONLAY INSERT.

Additional Manufacturer Narrative

AS PART OF NORMAL COMPLAINT F/U, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. AT THIS TIME THERE IS NO EVIDENCE THAT THE INFECTION WAS CAUSED BY ANY MAKO COMPONENTS NOR DUE TO THE MAKOPLASTY PROCEDURE. DUE TO THE EXTENDED TIME PERIOD BETWEEN THE PROCEDURE AND THE INFECTION, IT IS UNLIKELY THAT THE MAKOPLASTY PROCEDURE OR DEVICES CONTRIBUTED TO THE INFECTION. ADDITIONALLY, THE POLYETHYLENE INSERT WAS REPLACED WHICH IS COMMON PRACTICE WITHIN A WOUND INFECTION.