RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Dec 22, 2014 · Event occurred Nov 13, 2014
Report 3005985723-2014-00209 · MDR key 4381181
Device
Manufacturer
Mako Surgical Corp.Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2014 USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. THE SURGEON STATED TO A MAKOPLASTY SPECIALIST THAT DURING THE SURGERY THE TIPS OF THE BONE PINS "SHEARED OFF" DURING INSERTION OF THE PINS. THE BROKEN TIPS OF THE BONE PINS REMAINED EMBEDDED IN THE PT'S TIBIA POST OPERATIVELY.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVAL OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.