InjuryKRR
RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Nov 12, 2014 · Event occurred Oct 22, 2014
Report 3005985723-2014-00188 · MDR key 4258827
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE SURGEON HAD PERFORMED PARTIAL KNEE ARTHROPLASTY PROCEDURES USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS ON (B)(6) 2013. ON (B)(6) 2014 A DIFFERENT SURGEON PERFORMED A REVISION TO A TOTAL KNEE ARTHROPLASTY.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. FURTHER INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.