RESTORIS MULTICOMPARTMENTAL KNEE PROTHESIS
Received Jan 27, 2015 · Event occurred Dec 1, 2014
Report 3005985723-2015-00004 · MDR key 4491335
Device
Generic name
Compartmental Knee Prosthesis, Hsx, Npj, Hry
Manufacturer
Mako SurgicalLot number
1484291012
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT IS BEING COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.
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 IMPLANTED AN EXPIRED TIBIAL BASE PLATE. THE OUTCOME OF THE CASE WAS SUCCESSFUL. THE IMPLANT WAS EXPIRED AS OF 10/01/2014, TWO MONTHS BEFORE THE SURGERY.