InjuryKRR
RESTORIS MULTICOMPARTMENTAL KNEE PROTHESIS
Received Sep 3, 2014 · Event occurred Aug 13, 2014
Report 3005985723-2014-00124 · MDR key 4089872
Device
Generic name
Compartmental Knee Prosthesis, Krr, Hsx, Npj, Hry
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INFO IS OBTAINED.
Description of Event or Problem
THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROX THREE WEEKS AFTER SURGERY, THE PATIENT WAS TREATED FOR INFECTION, AND THE ONLAY TIBIAL INSERT COMPONENT WAS EXCHANGED.