RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Nov 21, 2014 · Event occurred Oct 21, 2014
Report 3005985723-2014-00192 · MDR key 4298263
Device
Generic name
Compartmental Knee Prosthesis, Krr, Hsx, Npj, Hry
Manufacturer
Mako SurgicalModel number
111140Lot number
06040711
Product problems
- Break
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 HAS BEEN INITIATED AT MAKO SURGICAL. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN FURTHER INFORMATION IS OBTAINED.
Description of Event or Problem
THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS TRIALING, HE INSERTED THE FEMORAL TRIAL INSERTER INSTRUMENT INTO THE FEMORAL TRIAL. WHEN HE DID THIS, THE INSERTER TIP SHEARED OFF INSIDE OF THE FEMORAL TRIAL. ANOTHER INSTRUMENT TRAY WAS OPENED AND THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.