Knee Implants and Big Medicine-What You Should Know!
You may or may not have heard about the FDA bringing the hammer down on Otismed, a subsidiary of Stryker the big knee replacement implant industry giant. In a nut shell, the CEO plead guilty to selling the The Otisknee, a cutting guide that helps surgeons align a “Custom knee” after the FDA denied the device 510K approval. See my guest post on NaturalNews.com, a site I highly recommend by the way, for the full story.
Below I have included a detailed chronology of the events from both Otismed and Stryker’s perspective. The story is not pretty, at least not for the knee replacement consumer. Now more than ever you need to be an educated buyer and stop listening to the marketing messages while blinding trusting healthcare professionals.
Timeline Facts
1) Between May 2006 and September 2009, OtisMed sold more than 18,000 OtisKnee devices, generating revenue of approximately $27.1 million.
2) On Oct. 2, 2008, OtisMed submitted a pre-market notification to the FDA seeking clearance to market the OtisKnee.
3) On Sept. 2, 2009, the FDA sent OtisMed a notice that its submission had been denied, noting that the company had failed to demonstrate that the OtisKnee was as safe and effective as other legally marketed devices.
4) Chi, The CEO of OtisMed directed employees to organize a mass shipment of all OtisKnee devices that had been manufactured but had not yet been shipped and suggested ways for the employees to hide the shipments from FDA regulators.
5) At Chi’s direction, OtisMed shipped approximately 218 OtisKnee guides from California to surgeons throughout the United States, including 16 to surgeons in New Jersey.
6) Chi faces a statutory maximum sentence of one year in prison and a $100,000 fine, or twice the gain or loss from the offense, for each of the three counts of introducing adulterated medical devices in interstate commerce.
7) Chi awaits sentencing by Judge Cecchi, on March 18, 2015.
Here’s the backstory that is actually far more disturbing and that will not be played on the media.
Stryker Timeline and Entanglements
1) Specifically, the settlement alleged that in May 2006, OtisMed, through co-promotion activities with Stryker Corporation, began commercially distributing the OtisKnee without having received clearance or approval from the FDA for the device. [Stryker a large Medical device company would have known FDA clearance had not been obtained]
2) On January 12, 2008 The Journal of Arthroplasty published a study on the OtisMed Custom Fit Knee. The results suggested that patients having an OtisMed Custom Fit Knee might experience early implant loosening or wear and eventual failure due to gross limb mal-alignment. Some surgeons reported aborting the surgery and using traditional techniques due to concerns during surgery.
3) On Oct. 2, 2008, OtisMed submitted a pre-market notification to the FDA seeking clearance to market the OtisKnee.
4) On Sept. 2, 2009, the FDA sent OtisMed a notice that its submission had been denied, noting that the company had failed to demonstrate that the OtisKnee was as safe and effective as other legally marketed devices. [Why did it take the FDA, one year to investigate this and come to a conclusion?]
5) Stryker announced the acquisition of OtisMed, in November 2009 despite obviously knowing that the device had issues and was being marketed without FDA Approval.
6) In 2010 Stryker was served with subpoena by the DOJ relating to sales and marketing of the OtisKnee, a device that has not been approved by the FDA
7) May 2011 Stryker’s announced FDA approval for the ShapeMatch Cutting Guide through 510(k) clearance [Note Stryker is able to get approval for cutting guides even though two years previously the FDA refused to approve the Otisknee stating that safety and effectiveness had not been demonstrated]
8) On May 31, 2012 Stryker offers 33 million to the DOJ to settle allegations of violations of federal laws related to sales of The OtisKnee not cleared by the U.S. FDA.
9) In January, 2013, 18 months after being approved, Stryker’s ShapeMatch Cutting Guide was formally recalled by the FDA with a Class I recall. Read more
10) On May 31, 2012 Stryker offered 33 million to the DOJ to settle allegations of violations of federal laws related to sales of a device (The OtisKnee) not cleared by the U.S. FDA.
Final Word On Knee Implants
The Consumer Union’s Safe Patient Project states …
Instead of pre-market safety testing, the FDA primarily relies on “post-market” reporting to Medwatch, a system for physicians and patients to report problems with implants. When enough problems or “signals” are reported, FDA may send out notice to the companies and the companies can choose to voluntarily recall their products. This means virtually every hip and knee implant patient is an unwitting participant in a giant, “post market” test to see which products are actually safe and which ones turn out to harmful or ineffective.
This is true only in the case of newly marketed versions of implants. There are implants with significant histories and track records already on the books. Select the “Honda Civic” of the knee implant models and you will be fine. Do not listen to marketing hype or you will be the test case.
Sources
Consumer Union Report
http://safepatientproject.org/press_release/consumers-union-calls-on-medical-device-makers-to-provide-warranties-for-hip-knee-implants
Dr. Stefan Kreuzer MD
http://www.stefankreuzermd.com/custom-fit-knee-replacement.html
Department of Justice
http://www.justice.gov/usao/nj/Press/files/Otismed%20News%20Release.html
FDA Source
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426134.htm
Gibson and Dunn
http://www.gibsondunn.com/publications/pages/2012YearEndHealthCareEnforcementUpdate.aspx
Depuy FDA Action
http://www.aboutlawsuits.com/depuy-warning-hip-implant-knee-replacement-product-12387/#sthash.E3LVlwOz.dpuf
Press Release
http://orthodoc.aaos.org/SportsMedicine/BP%20Otis%20Knee%20Press%20Release.pdf
21 replies to "10 Reasons Not To Trust Stryker for Your Knee Impant"
I have one of my these otisknees and have been complaining about it not feeling right for 9 years.
Have even had second opinions and bone scans that show it being loose but have been able to get no where with doing anything about it. Any advice
Donna
From RI
Hi Donna,
Sorry to hear about you having an otis knee. If I were you I would google otisknee lawsuits. Not that you neccessarily want to sue but talking to lawyers who deal with medical issues would give you an idea of how to get the medical field to respond and which doctors might be more willing to help with a revision surgery than others. The doctors are a close-knit community and are reluctant to take on someone else’s “problem” especially if it implicates the other doctor somewhat. You need to let the doctors know that you are knowledgeable about the problems associated with this implant and you need to see some action on correcting it. Hope that helps.
Hi Donna,
I was in the same situation!!!! ER’s and office visits always ended with everything is ok. But, after a visit to BAPTIST HOSPITAL and a great surgeon, I had two revisions done. What a difference!!!!! At the time I didn’t know anything about the Otis knee.
At the surgeries I asked for all parts taken out. Months later, I found a number on a piece, googled it and was SHOCKED.
How could they do that to us? All that pain for years!!!!
I am doing great now and I hope you are too.
Diane
from MA
I had the otismed knee by surgeon dr Richard Levitt who wrote the surgical protocol
Now 7 revision surgeries i cannot walk because he cut to much bone
I have no recourse because stryker attorney got my case dismissed
Witt vs Stryker
Sandy so sorry to hear about your situation. This is the reason I tell people to ask about the implant and make sure that the implant has been in use for at least 5-7 years. This is the only surefire way to avoid getting a product that could potentially need to be recalled. If a new product is faulty, it will usually begin failing in that time period.
Hello, I just made an appointment to have a total knee replacement. The Orthopedic Dr. I was given told me he used the Styker knee replacement device. He told me he did not have any material for me to read on the device,but that I should research Styker on the internet. Oh my word! All I saw was Lawsuit after lawsuit and people’s testimonies of what horrible experiences they have gone through because of Stryker knee replacements. I’m scared to death! Please give me your opinion on my delema.
Hi Michelle,
Check out this page for list of biggest offenders in terms of having to recall their equipment. https://www.drugwatch.com/knee-replacement/recalls/ Unfortunatly merely avoiding Stryker is not the answer, the problems is really with all of th top 5. The key is to get the right ethical Dr and to be unafraid to have a difficult conversation with him about his compensation from various manufacturers. Drs that are getting serious compensation from manufacturers may feel compeled to push the latest and greatest stuff, the things they are currently marketing and which drive stocks and quarterly reports. Most recalls take place in the first 5 years. Get the “honda civic” of implants, a proven reliable implant system that has been around longer than 5 years. Have that converstation with your ortho. If he gets angry or acts insulted it’s time to move on, in my humble opinion.
I just had a tkr 5 weeks ago, total trust in my doctor. I just saw this site and I have a Stryker implant. I’m concerned now, any advice.
Surgery was April 9 2019.
Thank you
Carol, The implant that your Dr. chooses to work with could be the newest version (basically untested) or an older tested model.
You have to have that conversation with your ortho and find out which model he used with you (write it down and put it somewhere safe) and why. Of course this is better done before surgery.
But hopefully your intuitition in trusting him will be borne out and things will be fine.
If you have any problems going forward remember to check with the recall list to make sure your model is not on the list in the future.
https://www.drugwatch.com/knee-replacement/recalls/
In 2020 I have a total knee replacement made by Stryker within 3 months I knew something was wrong I told my doctor it felt loose he says it can’t be loose well 8 months after the surgery come to find out it did come loose and the only way they found out it was loose was a bone scan so I had to go in and have a second total knee replacement this time you use bones cement but he also put my kneecap in crooked so I went and had a second opinion come to find out it came loose again plus I had metalosis they had it cut about an inch of my bone off my kneecap look like Swiss cheese they had all these holes the bone is starting to grow in the holes and the start and come back to life I guess it was September 2022 is when I had my third revision I still have the pain after 4 months and the popping is just ridiculous
I had a medial unicompartmental knee arthoplasty of left knee two years age. There is mild loosening around the tibial component. Implants were Smith and Nephew Stride. Should I be concerned about the loosening.
Hi Bonne,
I do not see any recalls on the implant you mentioned but yes you should be concerned about loosening. The most common reasons for revisions in unis are loosening and pain. There is ongoing debate and dicussion regarding whether uncemented or cemented unis are better. There is generally some “migration’ early on but should stabilze by 2 years. Pay attention and keep in touch with ortho.
Hello, Help Please. I am having a Totally Knee Replacement. Name of the Implant is Stryker “GetAroundKnee” on September 11, 2019. Is this a good updated Implant? All I am seeing are recalls and lawsuit. Should I ask for another implant and do you know which implant is the best with lesser risk factors? Thank you very much!
Hi Mr Bright,
According to drug watch Stryker hasn’t had a really serious recall since before 2014. Here is a good summary page https://www.drugwatch.com/knee-replacement/recalls/ Remember, for your own confidence sake, the first place to start is to have a conversation with your surgeon about the type implant he uses and why, as well as how long he’s used it and whether he has an financial incentive from stryker to use it. If you have any hesitation, get a second opinion with another ortho before you get the surgery. Do due diligence before the surgery so you won’t regret it later.
I am going for TKR next week and it is a Stryker product have a call in now to get info- wish I had seen this earlier
My Doctor uses the De Puy Synthes-Attune knee system. I see that there are lawsuits against this company, and that the knee has been failing, many times within 2 years. There has been no recall yet. Should I avoid this implant? How do I find out which ones have the best track record? Please tell me If there is a trustworthy place to get this information.
Yes I would avoid anything that has not been proven on the market for less than 5-7 years. https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0037-1603756. You NEVER want to be the guinea pig for testing a new model. You can access Maude database for issues, but honestly if you ask your ortho the hard questions like what his revision rates and the implants revision rates nationally, whether he gets consultant fees from the devise manufacturer, how long the implant has been in use etc. In other words find a surgeon you can trust that is not willing sacrifice his reputation for high “consulting” fees to implant new unproven models in his patients. BTW any new model is unproven. No clinical trials are done. They are fast tracked through 510K approval process.
I had a Stryker partial knee replacement in April 2019. At first all was good but about 3 month into physical therapy started have lots of pain when I put weight on it. At first Dr. stated all is good give it time but a month later I went back complaining and he did a xray. Found out the cement holding the device has separated from my lower bone. I have been in terrible pain and finally he is going to replace it with a full one this month. I have to come up with all money and copays again. No explanations just that it happens.
I had a Stryker knee put in 6/3/2019
Revision surgery 10/13/2020
Can’t find lawyer to take my case.
Is there a class action out there that I can join?
I’m desperate
[email protected].
Hi Michelle, Don’t know if this site of yours is still live, but I thought I’d ask you a question anyway. I have a Stryker Triathalon installed in 9/2019. I don’t think it has been recalled but I can’t tell. I have been in pain ever since. I have full ROM but it still gets very stiff and is always painful in the thigh area directly ABOVE my kneecap. I did extra therapy, weightlifting, swimming, and biking. It never changes or gets better. My doctor retired last year but blew me off when I complained about it. I’ve been to four other surgeons. I always get the same answer– the x-rays look fine. Good-bye. I even got tested for metal/cement allergies (LTT blood test) even tho my hips and other knee have all been replaced also. My other knee has been revised due to wear (DuPuy) and my one hip was recalled (Stryker) and revised. I was mildly allergic to three metals but since I have other implants I’m not sure what to think about those results. I am not working with any surgeon at this time. I think my surgeon used a cutting system but I don’t know which one. I know it wasn’t robotic or MAKO. He wasn’t using any of the computerized systems. I’m not sure what to do or who to go to. It seems no doctor wants to play detective. I was pretty active. Now I just sit here in pain. My dog hasn’t been on a walk in three yrs. I’m 67. Any suggestions?
Hi Paula,
Sorry to hear about your lingering knee problems. I looked up your implant in the FDA database and was able to find this,
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm It’s a very limited recall on specifc femoral parts (sizes) and only a level 2 recall which
is viewed as a medically reversible issue.
A metal allergy would tend to be a more global issue than you are describing–top of the knee.
Directly above your kneecap is a tendon. Usually that means inflammation in that area.
If you work it out too hard too soon you create inflammation. This can happen in a lot of outpatient settings.
It’s possible that the original rehab was too aggressive and promoted high amounts of inflammation from the start which caused you to back off causing the knee tendon to stay weak.
That scenario would lead to chronic inflammation anytime you try to use it actively in your regular pursuits and thus the cycle of pain.
I would try strengthening but in a very slow progressive fashion – very low loads in a higher frequency with plenty of icing.
Like a wt cuff at home and at the same time protecting it from higher loads in the course of your day- excessive stair climbing squats etc.
So tlc for body wt movements at large and freq low loads to build up the tensile strength of that tendon. I hope that helps. Let me know how it goes.