RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Jan 9, 2015 · Event occurred Dec 10, 2014
Report 3005985723-2014-00210 · MDR key 4428040
Device
Generic name
Compartmental Knee Prosthesis, Krr, Hsx, Npj, Hry
Manufacturer
Mako SurgicalModel number
180607Lot number
1484291012
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Alteration In Body Temperature
Narrative
Description of Event or Problem
THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. THE SURGEON KNOWINGLY IMPLANTED AN EXPIRED TIBIAL BASE PLATE. THE OUTCOME OF THE CASE WAS SUCCESSFUL. THE IMPLANT EXPIRED AS OF 11/2014, ONLY A MONTH BEFORE THE SURGERY.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT F/U, AN EVAL OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADD'L INFO IS OBTAINED.