RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Aug 29, 2014 · Event occurred Aug 4, 2014
Report 3005985723-2014-00119 · MDR key 4106466
Device
Generic name
Compartmental Knee Prosthesis- Krr, Hsx, Npj, Hry
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Failure of Implant
Narrative
Description of Event or Problem
PATIENT'S HUSBAND CALLED MAKO SURGICAL AND STATED THAT HIS WIFE HAD MAKOPLASTY PROCEDURES USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. HE STATED THAT HER BODY SEEMED TO BE REJECTING THE IMPLANTS, AND HE WANTED TO KNOW THE MATERIAL COMPOSITION OF THE IMPLANTS SO SHE COULD SEEK MEDICAL TREATMENT.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. A RESPONSE WAS PROVIDED TO THE PATIENT WITH THE MATERIAL COMPOSITION OF THE IMPLANTS. THE INVESTIGATION IS CURRENTLY ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.