RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Received Oct 21, 2014 · Event occurred Sep 27, 2014
Report 3005985723-2014-00177 · MDR key 4208649
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako SurgicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
05/31/1
- Pain
Narrative
Description of Event or Problem
THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE IMPLANTS ON (B)(6) 2014. POST OPERATIVE X-RAYS SHOWED ACCURATE COMPONENT PLACEMENT. THE PT LATER COMPLAINED ON PAIN MID-THIGH. ANOTHER X-RAY WAS PERFORMED WHICH SHOWED A FEMUR FRACTURE ALONG THE PIN-HOLE ENTRY SITES. THE SURGEON COMMENTED THAT THE PT HAS RHEUMATOID ARTHRITIS AND VERY SOFT BONE.
Additional Manufacturer Narrative
THE FOLLOWING IS A SUPPLEMENTAL REPORT TO THE ORIGINAL MDR SUBMITTED PREVIOUSLY. ADDITIONAL INFORMATION REGARDING THE EVENT IS PROVIDED HEREIN. SYSTEM DATA REVIEWED AND DAT SUGGESTS THE SYSTEM OPERATED AS EXPECTED. NO EVIDENCE OF SYSTEM MALFUNCTION. FEMORAL FRACTURE LIKELY CAUSED DUE TO STRESS CONCENTRATION FROM BONE PIN HOLES & SOFT BONE QUALITY DUE TO PATIENTS RA CONDITION.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. NO FURTHER INFO IS KNOWN AT THIS TIME. INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN RESULTS ARE OBTAINED.