NATURAL KNEE II SYSTEM-RIGHT KNEE
Received Dec 1, 2014 · Event occurred Sep 1, 2012
Report MW5039314 · MDR key 4295022
Device
Product problems
- Device Slipped
Patient
56 YR
- Fall
- Discomfort
Narrative
Description of Event or Problem
PT CALLED TO REPORT ADVERSE REACTIONS CAUSED BY HER NATURAL KNEE II SYSTEM-RIGHT KNEE. PT STATED THAT IN (B)(6) 2012, HER RIGHT KNEE GAVE OUT AND SHE FELL. SHE ALSO SAID HER SHIN WAS VERY SORE. SHE SAID SHE WAS SEEN BY A PHYSICIAN WHO TOLD HER THAT HER RIGHT KNEE IMPLANT WAS EITHER LOOSE, OR SHE HAD AN INFECTION. IT WAS CONFIRMED BY A PHYSICIAN THAT THE CEMENT IN THE RIGHT KNEE IMPLANT HAD COME LOOSE. SHE STATED THAT UP UNTIL (B)(6) 2012, THE RIGHT KNEE IMPLANT NEVER REALLY FELT RIGHT, SHE SAID IT FELT TIGHT. SHE SAID SHE HAS SPOKEN WITH 10 ATTORNEYS, AND WAS TOLD THIS IMPLANT WAS NOT ONE THAT WAS RECALLED. PT IS VERY UPSET.