RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Dec 3, 2014 · Event occurred Nov 6, 2014
Report 3005985723-2014-00198 · MDR key 4349559
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalModel number
180614Lot number
26080714-01
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVAL OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.
Description of Event or Problem
THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. PRIOR TO IMPLANTING THE TIBIAL BASEPLATE, THE SURGEON NOTICED THERE WAS A DARK SPOT ON THE UNDERSIDE OF THE IMPLANT. THE IMPLANT WAS NOT USED AND A NEW IMPLANT WAS OPENED AND USED. THIS EVENT DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.