RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Nov 7, 2014 · Event occurred May 25, 2012
Report 3005985723-2014-00187 · MDR key 4251777
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR
- Pain
Narrative
Description of Event or Problem
THE SURGEON PERFORMED A BIOCOMPARTMENTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS ON (B)(6) 2012. THE PT LATER COMPLAINED OF KNEE PAIN. FIVE MONTHS FOLLOWING THE SURGERY, THE PATIENT SAW A DIFFERENT SURGEON WHO DID A X-RAY THAT SHOWED "METAL O METAL" AND A DISLODGED INSERT COMPONENT. ON (B)(6) 2014 THE PT UNDERWENT A TOTAL KNEE REVISION SURGERY. FOLLOWING THE REVISION PROCEDURE, THE PATIENT WAS INFORMED THAT THE SURGICAL TEAM WAS "UNABLE TO REMOVE ALL THE METAL SCRAPINGS". THE PT REPORTS "PAIN, SWELLING AND INFLAMMATION" AS WELL AS DIFFICULTY WALKING.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.