RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Dec 10, 2014 · Event occurred Nov 17, 2014
Report 3005985723-2014-00202 · MDR key 4344883
Device
Generic name
Compartmental Knee Prosthesis, Krr, Hsx, Npj, Hry
Manufacturer
Mako SurgicalModel number
180616Lot number
26120812-01
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 WAS 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 KNOWINGLY IMPLANTED AN EXPIRED TIBIAL BASE PLATE. THE OUTCOME OF THE CASE WAS SUCCESSFUL. THE IMPLANT WAS EXPIRED AS OF (B)(6) 2014, ONLY A MONTH BEFORE THE SURGERY.