OVAL DOME PATELLA 3-PEG 25MM
Received Jun 27, 2013 · Event occurred Mar 19, 2009
Report MW5030728 · MDR key 3204025
Device
Product problems
- Device Operates Differently Than Expected
Patient
55 YR
- Pain
- Swelling
- Depression
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
IN (B)(6) OF 2009, I HAD A TOTAL RIGHT KNEE REPLACEMENT. ALMOST IMMEDIATELY I TOLD MY SURGEON THAT SOMETHING WAS WRONG. HE SAID GIVE IT SOME TIME AND IT WOULD GET BETTER. IT HASN'T GOTTEN BETTER AFTER FOUR YEARS. SIX MONTHS AFTER THE RIGHT KNEE REPLACEMENT, I ALLOWED THE SURGEON TO DO MY LEFT KNEE. HE PUT A DIFFERENT TYPE OF APPLIANCE IN THE LEFT KNEE. HE SAID IT WAS THE OLDER MODEL, WHERE AS THE RIGHT KNEE HAD THE APPROVED MODEL, BUT HE SAID SINCE I WAS STILL COMPLAINING ABOUT THE RIGHT KNEE, HE WENT BACK TO THE OLD MODEL. THE SURGEON TOLD ME IN THE EARLY PART OF 2010 THAT HE WOULD REMOVE THE RIGHT KNEE APPLIANCE IN (B)(6) OF THAT YEAR. WELL, I WENT IN TO MAKE ARRANGEMENTS FOR THE REMOVAL OF THE RIGHT KNEE IMPLANT IN (B)(6) AND THAT IS WHEN HE TOLD ME HE WAS NOT GOING TO REMOVE IT AND HE WOULD NOT DO MRI; ONLY MORE PHYSICAL THERAPY WITH PAIN MEDICATION. THE PHYSICAL THERAPY DID NOT HELP, AND I HAVE CONTINUED DEVELOPING ADDITIONAL MEDICAL PROBLEMS. I DEVELOPED A GATE THAT HAS AGGRAVATE MY BACK PROBLEMS AND IS CAUSING ME TO STRESS THE LEFT KNEE, LEG, AND FOOT. MY LEFT FOOT HAS BEEN BROKEN TWICE BEFORE ALL OF THIS AND I NOW HAVE GOUT AND BOTH KNEES HURT ALL THE TIME. I SEE A NEUROLOGIST FOR THE NERVE PAIN. I HAVE A PAIN MANAGEMENT DR THAT GIVES ME INJECTIONS FOR THE KNEE AND PACK PAIN. MY PAIN MEDICINES HAVE INCREASED. I WAS SEEING A MENTAL HEALTH DOCTOR FOR DEPRESSION. I TRY TO STAY ACTIVE, BUT IT IS BECOMING MORE DIFFICULT. I AM ONLY (B)(6). THE RIGHT KNEE JUST WILL NOT BEND PROPERLY AND IT IS SWOLLEN AND HOT ALL THE TIME. THE SURGEON'S ASSISTANTS WANTED TO CHECK FOR INFECTION BUT HE SAID NO. I TERMINATED HIS SERVICE IN (B)(6) 2010 AND HAVE TRIED TO GET TWO OTHER DOCTORS TO LOOK AT ME.