RESTORIS MULTIPCOMPARTMENTAL KNEE PROSTHESIS

Additional Manufacturer Narrative

AS PART OF A NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. VERBAL CONFIRMATION WAS RECEIVED FROM SURGEON THAT THE JOINT DID NOT FEEL TIGHT AFTER THE REVISION PROCEDURE. THE TIBIAL BASEPLATE WAS SECURE AND NOT LOOSE. THERE WAS NO EVIDENCE OF ANY DEBRIS OR CEMENT IN THE JOINT NOTED DURING THE REVISION. THE IMPLANTS WERE TAKEN AND SENT TO PATHOLOGY; THE IMPLANTS HAVE BEEN REQUESTED FOR RETURN TO MAKO, BUT IT IS UNK WHETHER THEY WILL BE RETURNED AT THIS TIME. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INFO IS OBTAINED.

Description of Event or Problem

THE PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY PROCEDURES USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROXIMATELY 18 MONTHS AFTER THE PROCEDURE, THE PT COMPLAINED OF PAIN. THE SURGEON EVALUATED THE JOINT IN A OPEN PROCEDURE, AND OBSERVED SOME WEAR IN THE LATERAL CONDYLE, AS WELL AS SOME CHANGES IN THE PATELLOFEMORAL REGION OF THE JOINT. THE PHYSICIAN'S ASSISTANT STATED THAT THE POSTERIOR ASPECT OF THE FEMORAL COMPONENT MAY HAVE BEEN CATCHING ON SOME BONE GROWTH IN THE POSTERIOR REGION. THE FEMORAL COMPONENT WAS EXTRACTED, WITH NO LOOSENING NOTED BY THE SURGEON. THE FEMORAL COMPONENT AND THE ONLAY TIBIAL INSERT COMPONENT WERE REPLACED BY THE SURGEON WITH COMPONENTS OF THE SAME SIZE.