FDA Stryker letter

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Swright

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Jun 19, 2007
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Okay,

Just when I was feeling good about getting my THR in March, the FDA letter to Stryker rears its head....and Stryker products are the only products my OS uses.

You can go to this site to read about it
broken link removed: https://www.cnbc.com/id/22688552/for/cnbc?__source=RSS*tag*&par=RSS

This is scary stuff, and when I read the letter which has to much medical gargon for me to understand it makes me want to run from my OS and look for one who doesn't use Stryker.

Then again, what this site does not say is how many people have had success stories using Stryker.

I'm thinking rather than running, I should make an appointment with my OS and ask him what he would do, if anything to prevent the problems I read about from happening when he performs my surgery.

It's taken me nearly two years to be comfortable with my decision, and find an OS with a wonderful reputation who supports my decision even though I'll be only 47 at the time of surgery. The idea of getting back out there and going office to office to start my search over is depressing.

Any thoughts are appreciated
 
Wow - no wonder you feel scared! It's a popularly held opinion here in the UK that the FDA is somewhat over zealous over these things.

However, I will do my best to address some of the issues raised in that article.

...has received patient complaints since January 2005 about a range of problems, including improper fitting of hip implants that caused bone fractures. Patients also have complained about pain, difficulty walking and "squeaky" joins, and some have had pieces of implant parts break off or wear down unevenly.

I said this sooo many times on here but I will continue to say it; "improper fitting of implants" is poor surgical technique and nothing to do with the implants. You can get failure of your brakes if your car mechanic doesn't fit the brake shoes properly! That is not the fault of the brake shoes. The same for all the other problems mentioned. And the breakages and uneven wear is also 95% due to faulty positioning.

To be honest, I can't quite see how they can require the firm to "perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems". It's ridiculous!

I'm also intrigued by the "FDA noted that some parts of the plant were found to be contaminated with disease-causing germs, including "clumps and clusters" of a form of Staphylococcus bacteria". It's a factory, for goodness sake, and has been operating for years. And it's not like the implants are used straight off the production line. They are washed and cleaned, packed into their containers and then subjected to Gamma radiation to be sterilized. If these comments were aimed at food production I would heartily concur but I hardly think this draconian attitude is necessary in this instance.

Finally, think on this ... your surgeon has been using these products for a number of years. It is apparent he has confidence in them. Trust me, if he had any reason to agree with this report, he would have a) known about it long ere this and b) dropped Stryker like a hot potato! He has a lot to lose from continuing to use a prosthesis that is plagued with problems and failures. Like his livelihood for starters!! Go back and talk to him. Take a hard copy of that article and ask him his opinion. He will be happy to give you his take on it, I am sure.


Let us know how you get on.
 
Thank you very much for your response.

I've posted on other hip replacement boards regarding the fact that the letter doesn't address the issue of "poor placement by OS" vs. structural problems resulting in placement. It seems no one has that answer. I think the answer is unless they have a surgeon who uses all brands of hip replacement hardware and has problems with early revision they can't pin point wether it's the OS or the harware. They do suggest that the standards in manufacturing the Trident cup aren't sufficient, so there must be "evidence" of these problems within the manufacturing.

My OS is a representative for Stryker and works in research with the company. I hope he will be honest with me, my suspicious side thinks that when you are a partner in a business your more apt to side with the business....

Thanks again.

I'm hoping that people with good results from Stryker implants come forward.
 
I take your points and I understand your natural concerns. But I really cannot envisage how poor placement can be due to a faulty implant design. I have been around this stuff for 40 odd years and seen good surgeons and bad, I have seen good surgeons make errors and bad surgeons do excellent jobs. I have seen surgeons choose the wrong unit for the patient as well, either in the product or the choice of size. But to my knowledge I have never seen a situation where the implant was responsible for the placement. To me it just defies logic.

Similarly, it hardly seems equitable that the manufacturer should be held responsible for the surgeon's surgical skills. That, to my mind, is something that can only be laid at the door of the surgeon.

But I would be most interested to know what other information you glean in your search.
 
A very interesting study.Thank you for bringing them to my attention. I had not realised it was referring to the placement of the three components of the acetabular cup. It's also interesting that the US surgeons had different experiences to the British ones. I will be keeping my ear to the ground for further developments ...
 
Sounds like the problem of deforming the metal shell that holds the ceramic or poly is not only a Stryker problem. I'm sure if I took the time I could find more companies that have information reflecting problems. It is always a risk when you put your "HIPS" in someones hands. Even with the best surgeon there are many variables that he/she isn't aware of until they are in the midst of surgery. I'm interested as to my OS's responses when I bring this FDA letter up to him.

I have a feeling that other than the acetabular shell, issue I'm not sure anything else he uses is noted in the report.


https://www.sciencedirect.com/scien...serid=10&md5=9311760de456589a394c9ab5c8915b61
 
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