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Knee Implant Problems - FDA Consumer Complaint
hopeful15 posted:
My dearest friend had TKR with a DePuy Sigma Knee in 2007. He has swelling, pain, stiffness, warm to the touch, and SO MANY restless nights. Since 2007 he has had two additional surgeries. Earlier this spring/summer he underwent a total knee revision. It has not been easy. It really makes me sad to hear so many people are facing a very similiar situation. I think if more people reported their medical complaints to the FDA that would prompt the FDA to investigate consumer concerns more quickly. People who have been legitamately hurt by medical devices and drugs do have a voice. In my opinion if enough people let their voices and experiences be heard action make be taken. You can google search "fda medwatch" or click on the link below to the website.
The instructions indicate that your privacy will be protected if you make the request. Spread the word and best of luck to everyone.
arbob5 responded:
I had a TKR 7 years ago and while I do not know the manufacturer of that "new knee" (I'll have to dig out the paperwork on that surgery), I can honestly say that I had no problems whatsoever, other than the normal pain and healing process. I expected it to be worse than it was, after hearing from friends who were not as fortunate with their knee surgeries. I'm so sorry that your friend has had so many problems.

My surgeon performed both of my THR's (the most recent hip replacement was 7/16/2012) and my TKR, and I can only say that he is the reason for my successful surgeries. I do not know how else to explain it. I was informed before all my surgeries, exactly what to expect, and there were absolutely no surprises whatsoever. I am very fortunate.

After my most recent surgery which took less than an hour, I commented to him "thanks for the great job", and his comment to me was "I've got a great team". I certainly did appreciate his humility. Not a lot of surgeons have that.

I do agree that the FDA needs to investigate these complaints more thoroughly. There has to be an answer to these problems and we have every right to expect the FDA to find them. I am firm believer that consumer concerns are so often put on the back burner. And who knows why. It should not be that way. As tax payers, we have a right to know what in the world is going on with so many of our complaints and problems. I guess we just have to keep on complaining, hoping that one of these days, someone will listen to us!
hopeful15 replied to arbob5's response:
Arbob5 you are so blessed and fortunate to be doing well. My friend has a new doctor who is part of a high profile orthopedic group. We are confident that he will get my friend where he needs to be. The knee isn't quite where it needs to be for daily activities. Manipulation is on the horizon. As the caregiver/friend/loved one it is so hard to see the person you care about in so much pain for extended periods (5yrs) of time well beyond the normal recovery time frame.

I've decided to take a stand and encourage people to take the time to voice their legitamate complaints/concerns to the FDA for their medical device and pharmaceutical adverse effects. The form is not long and all you have to do is explain. He has all his medical information so it took about 1 hour to complete. It would have taken less time, but we went over it several times because we wanted to be accurate and honest. Its a small step but I felt better afterwards.

All the best to you!
arbob5 replied to hopeful15's response:
We all need to take part in this because it will benefit all of us, regardless of what kind of implant or other medical problem stems from equipment, etc. It involves all of us. I will do my best and try to contact them.

Helpful Tips

I had my TKR done 6/30/15, and am back to work now. When I look back 3 mo. I can't believe how far I have come for the better. I also was ... More
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Report Problems With Your Medications to the FDA

FDAYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

For more information, visit the Duke Health Joint Replacement Center