MalfunctionKRR
RESTORIS MULTICOMPARTMENTAL KNEE PROTHESIS
Received Sep 5, 2014 · Event occurred Aug 14, 2014
Report 3005985723-2014-00126 · MDR key 4092994
Device
Generic name
Compartmental Knee Prothesis, Krr, Hsx, Npj, Hry
Manufacturer
Mako SurgicalProduct problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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. DURING TIBIAL IMPACTION, THE TIP OF THE TIBIAL INSERT IMPACTOR BROKE.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVAL OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE EVAL IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INFO IS OBTAINED.