RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Jan 9, 2015 · Event occurred Dec 15, 2014
Report 3005985723-2015-00001 · MDR key 4428021
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Post Operative Wound Infection
Narrative
Description of Event or Problem
A PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROX ONE MONTH LATER, THE PT PRESENTED WITH SIGNS OF A POSSIBLE INFECTION, AND THE SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) PROCEDURE AND EXCHANGED THE TIBIAL ONLAY INSERT COMPONENT.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT F/U, AN EVAL OF THE EVENT HAS BEEN INITIATED BY MAKE SURGICAL. AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST THAT THE RIO OR MCK IMPLANTS CONTRIBUTED TO THE INFECTION. THE SURGEON TOOK CULTURES FROM THE PT'S WOUND SITE TO CHECK FOR INFECTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.