Concern over Zimmer Implant
- Thread starter JDC
- Start date
- Status
parla
member
Hi,
As a patient who has a Zimmer Nexgen LPS flex THAT HAS BEEN RECALLED... I would be very concerned. I have to have a revision and I am very upset and in a huge amount of pain. You may want to read my story in the recovery forum. " TKR complications and recall". Bonesmart will probably edit or delete this because they are very defensive of Zimmer,( one of their sponsors I assume)... and bonesmart is 100% sure the implant is not my problem but surgeons error. I don't know all the facts yet, but I do know I am upset that I have a knee that has been RECALLED..... I don't think I need to say anymore, EXCEPT "tried and true " may be better than "latest and greatest."
Parla : (
As a patient who has a Zimmer Nexgen LPS flex THAT HAS BEEN RECALLED... I would be very concerned. I have to have a revision and I am very upset and in a huge amount of pain. You may want to read my story in the recovery forum. " TKR complications and recall". Bonesmart will probably edit or delete this because they are very defensive of Zimmer,( one of their sponsors I assume)... and bonesmart is 100% sure the implant is not my problem but surgeons error. I don't know all the facts yet, but I do know I am upset that I have a knee that has been RECALLED..... I don't think I need to say anymore, EXCEPT "tried and true " may be better than "latest and greatest."
Parla : (
Parla, we are not defensive of Zimmer - please don't misquote me. And their being one of our sponsors has nothing to do with anything on here. I could care less who are our sponsors when I am discussing such an issue with a member. But if you make comments like that again, I shall most certainly edit it out. And BoneSmart never said it was 100% sure about the implant - I did.
Parla, I resent the implication that "BoneSmart" (I'm assuming you mean either Josephine or me) would delete or edit a post you made where you were expressing your opinion.
We simply do not do that here and I would appreciate it if you would not make accusations like this in the future. We may post viewpoints that do not agree with yours, but no member's posts would ever be edited or deleted as you have suggested to somehow fit with a "BoneSmart" point of view.
While Zimmer is a sponsor of BoneSmart, as Josephine has explained to you in past posts, we are not guided by them nor anyone else within our parent organization as to what information and opinions we express here on the BoneSmart forum. This forum strives to present unbiased and truthful information. We have no other agenda other than to help people like you who have questions or concerns.
I know you are upset that you must have a revision to your knee and I will write off your comments regarding us to your anxiety. All Josephine and I have been trying to do is to help you.
No one can say for sure what is giving you problems with your knee at this point. I know this is frustrating to you but it happens this way sometimes and the only thing that can be done is to replace it.
Until a medical professional tells you the implant failed, my opinion based on the information I have seen is that your pain is more likely resulting from the surgical procedure itself. You may not agree with my assessment and that is certainly your right.
If you are going to post information to another member about recalls, I would appreciate it if you would provide complete and accurate information. You have done a lot of research on this matter and I know you have all the information plus links to specific documents that you could provide so that people could make up their own minds.
Not all Zimmer Nexgen LPS flex implants were involved in this particular recall notice....only specific lots, one of which was your knee implant. The recall was not considered a high risk to patients and surgeons and the FDA did not issue a public recall notice because of this fact. The recall was done as a precautionary measure, which is not uncommon. The fact that a Class II recall notice was issued does not mean that all the implants in the numbered lots would result in a problem for a patient.
The concern was a minor design flaw in the implant which Josephine showed in your thread. Based on her experience in orthopedics, she felt this would not result in the type of pain you are experiencing.
I look forward to hearing what your surgeon has to say once you meet with him again. And I definitely am looking forward to your upcoming revision, as I believe you will finally get some relief from the pain you are experiencing.
We simply do not do that here and I would appreciate it if you would not make accusations like this in the future. We may post viewpoints that do not agree with yours, but no member's posts would ever be edited or deleted as you have suggested to somehow fit with a "BoneSmart" point of view.
While Zimmer is a sponsor of BoneSmart, as Josephine has explained to you in past posts, we are not guided by them nor anyone else within our parent organization as to what information and opinions we express here on the BoneSmart forum. This forum strives to present unbiased and truthful information. We have no other agenda other than to help people like you who have questions or concerns.
I know you are upset that you must have a revision to your knee and I will write off your comments regarding us to your anxiety. All Josephine and I have been trying to do is to help you.
No one can say for sure what is giving you problems with your knee at this point. I know this is frustrating to you but it happens this way sometimes and the only thing that can be done is to replace it.
Until a medical professional tells you the implant failed, my opinion based on the information I have seen is that your pain is more likely resulting from the surgical procedure itself. You may not agree with my assessment and that is certainly your right.
If you are going to post information to another member about recalls, I would appreciate it if you would provide complete and accurate information. You have done a lot of research on this matter and I know you have all the information plus links to specific documents that you could provide so that people could make up their own minds.
Not all Zimmer Nexgen LPS flex implants were involved in this particular recall notice....only specific lots, one of which was your knee implant. The recall was not considered a high risk to patients and surgeons and the FDA did not issue a public recall notice because of this fact. The recall was done as a precautionary measure, which is not uncommon. The fact that a Class II recall notice was issued does not mean that all the implants in the numbered lots would result in a problem for a patient.
The concern was a minor design flaw in the implant which Josephine showed in your thread. Based on her experience in orthopedics, she felt this would not result in the type of pain you are experiencing.
I look forward to hearing what your surgeon has to say once you meet with him again. And I definitely am looking forward to your upcoming revision, as I believe you will finally get some relief from the pain you are experiencing.
DebR
member
Parla, I have been following along on your posts. It seems to me that you are angry this is happening and I get it!! But, any information given to you makes you very combative. I had a partial done 1 1/2 yrs ago and then had a revision to a RTKR 3 1/2 months ago. The OS that performed my most recent surgery said that the partial basically fell into pieces in his hands when he removed it. I blamed a lot of people for a while, the original OS, the implant makers etc. The bottom line is, the only thing that matter's in the long run is to be as pain free as possible. I was in CONSTANT pain from the time I had the partial until I had it revised. Not a pleasant way to live. I came on this site with all kinds of questions regarding pain, my mood and a hundred others. I have always found any answers I got to be right from the heart!!! There is no partiality on this site for any knee implant maker, and sometimes really crappy things happen!! This was my 4th surgery on this knee and I did the best I could with the info I had from the doctor's. What helped me through was the support I received HERE. Nobody get's it better. I am sorry you are in pain all the time, I am sorry there may be an issue with the implant, but regardless of the reason you need to get this fixed however you can. If that mean's a revision, then that is what to do. No the surgery isn't pleasant but the outcome could be wonderful. At this point, how much longer are you going to live in this pain? If you come on this site to pose questions, please take the answers as they are intended, and that is simply to help. You will never find the answers in articles, you will find them from people that have been exactly where you are.
parla
member
I am sorry if are having trouble understanding that it is VERY disturbing to have something inside your body recalled. I have learned that FDA is fast tracking potentially unsafe products based upon performance of similar products. I did not realize this was happening in my country and I want to prevent people from suffering unnecessarily. I am suggesting that people proceed with CAUTION and be very careful with what they chose or allow to be placed in their bodies and I don't think that is unreasonable.
Parla
Parla
RestAssured
BoneSmart Staff
Parla,
Forgive my ignorance, but do you think that the FDA would let any more of the knees like you have go out? I mean that particular component?
I would think that the problem has been fixed since the company has been alerted.
Just a thought.:WINK1:
Forgive my ignorance, but do you think that the FDA would let any more of the knees like you have go out? I mean that particular component?
I would think that the problem has been fixed since the company has been alerted.
Just a thought.:WINK1:
Exactly, Sonja. The recall was simply to remove all existing stock from the shelves so no more of them would be used.
For the benefit of all those reading here, I would emphasise again that the error was a purely technical one that will not impact upon the efficiency of the prosthesis' function at all but does mean the product doesn't comply with the legal specifications. This is the only reason it was recalled and a Class 2 recall applied. Had there been any other more serious issue, a Class 1 recall would have been issued and a notice would have gone out requiring all recipients of said implant to be called in for appraisal and long term follow-up, as they did with the Durom cup. No such action has been required and those with this implant in situ are expected to have a normal longevity with this product.
For the benefit of all those reading here, I would emphasise again that the error was a purely technical one that will not impact upon the efficiency of the prosthesis' function at all but does mean the product doesn't comply with the legal specifications. This is the only reason it was recalled and a Class 2 recall applied. Had there been any other more serious issue, a Class 1 recall would have been issued and a notice would have gone out requiring all recipients of said implant to be called in for appraisal and long term follow-up, as they did with the Durom cup. No such action has been required and those with this implant in situ are expected to have a normal longevity with this product.
parla
member
We simply do not do that here and I would appreciate it if you would not make accusations like this in the future. We may post viewpoints that do not agree with yours, but no member's posts would ever be edited or deleted as you have suggested to somehow fit with a "BoneSmart" point of view.
Above from jamie
Any further references to this issue on this forum will be edited by staff.
Above from Josephine
My reply was " Why?" and was deleted...
So why are we not allowed to talk about it? I don't understand why you would not care to protect people even if you don't agree that the knee itself may be a problem. I don't even know what I think for sure until the recalled product comes out... That is reasonable because I agree all facts are not yet in evidence.
I have a messed up knee and need revision surgery which is naturally upsetting and since my implant was recalled down to the serial number, I don't understand why I can't discuss it?
Parla
Above from jamie
Any further references to this issue on this forum will be edited by staff.
Above from Josephine
My reply was " Why?" and was deleted...
So why are we not allowed to talk about it? I don't understand why you would not care to protect people even if you don't agree that the knee itself may be a problem. I don't even know what I think for sure until the recalled product comes out... That is reasonable because I agree all facts are not yet in evidence.
I have a messed up knee and need revision surgery which is naturally upsetting and since my implant was recalled down to the serial number, I don't understand why I can't discuss it?
Parla
Parla, the three posts you are refering to were removed because they were off topic for this thread. I discussed your question with Josephine and we agree there is no problem with you discussing your knee issues or the Zimmer recall.
However, I will still caution you about making statements about BoneSmart or our staff that are incorrect. That would include comments that suggest Jo or I would edit facts from your posts to make your comments fit with ours or that we phrase our opinions in a way that benefits sponsors of BoneSmart simply because they are sponsors.
In fact, if you had left the following sentences out of your post #23 above, we would probably not even be having this discussion, as neither Jo nor I would have had a problem with it.
"Bonesmart will probably edit or delete this because they are very defensive of Zimmer,( one of their sponsors I assume)... and bonesmart is 100% sure the implant is not my problem but surgeons error."
Jo and I care very deeply about you, our members, and those who choose to just lurk and read BoneSmart on their own. I encourage you to talk about your concerns and questions and even about the recall if that is of help to you.
Now, since THIS post is really way off topic, I would like it to be the last of our discussion in this thread about what may be posted and why. If you have any additional questions, please send Jo and/or me a private message and we can talk about it more there.
However, I will still caution you about making statements about BoneSmart or our staff that are incorrect. That would include comments that suggest Jo or I would edit facts from your posts to make your comments fit with ours or that we phrase our opinions in a way that benefits sponsors of BoneSmart simply because they are sponsors.
In fact, if you had left the following sentences out of your post #23 above, we would probably not even be having this discussion, as neither Jo nor I would have had a problem with it.
"Bonesmart will probably edit or delete this because they are very defensive of Zimmer,( one of their sponsors I assume)... and bonesmart is 100% sure the implant is not my problem but surgeons error."
Jo and I care very deeply about you, our members, and those who choose to just lurk and read BoneSmart on their own. I encourage you to talk about your concerns and questions and even about the recall if that is of help to you.
Now, since THIS post is really way off topic, I would like it to be the last of our discussion in this thread about what may be posted and why. If you have any additional questions, please send Jo and/or me a private message and we can talk about it more there.
parla
member
If the title of the thread is "Concern over Zimmer Implant" how is it "off topic"? Honestly I do not understand. 100% perplexed by your answer.
Parla
Parla
BigGene
graduate
Let me help.
Talkjng about recall is fine.
Accusing bonesmart personel of colusion or lying is not.
Let it go, please.
We all want you to get well, move foreward.
Talkjng about recall is fine.
Accusing bonesmart personel of colusion or lying is not.
Let it go, please.
We all want you to get well, move foreward.
Thank you, Big Gene!
Parla, I cannot make it any more clear.
If you want to talk on this thread or any other one about your knee, about the Zimmer recall or to respond to someone about these topics, that's fine.
Just stop bashing BoneSmart and its staff.
Parla, I cannot make it any more clear.
If you want to talk on this thread or any other one about your knee, about the Zimmer recall or to respond to someone about these topics, that's fine.
Just stop bashing BoneSmart and its staff.
referee54
Former BoneSmart staff member
- Joined
- Dec 21, 2007
- Messages
- 17,881
- Age
- 69
- Location
- Northern Part of the Buckeye State
- Country
United States
- Gender
- Male
Bingo. Succinct and to the point. "nough said.
parla
member
I am very sad that:
3 people have accused me of saying people were "lying" and that is 100% not true.
I stated that I suspected some lack of impartiality but that does not make me correct. I have been hurt emotionally by people turning that into "bashing" and other harsh terms I have not used.
I have been through a lot whether we agree on the reason or not please stop scolding me and distorting things. I would have "let it go" if I was not misquoted repeatedly and if I had no feelings.
And to answer Sonja's question about "don't I feel better since the product was taken off the shelves"... I do, but that does not negate the fact that I have a knee that does not work for no known reason. I do know I have a knee that MAY have a defective component, and that makes me sad, and at this point I just need to move forward. We at least agree on that.... moving forward but I have to clear the air.
Parla
3 people have accused me of saying people were "lying" and that is 100% not true.
I stated that I suspected some lack of impartiality but that does not make me correct. I have been hurt emotionally by people turning that into "bashing" and other harsh terms I have not used.
I have been through a lot whether we agree on the reason or not please stop scolding me and distorting things. I would have "let it go" if I was not misquoted repeatedly and if I had no feelings.
And to answer Sonja's question about "don't I feel better since the product was taken off the shelves"... I do, but that does not negate the fact that I have a knee that does not work for no known reason. I do know I have a knee that MAY have a defective component, and that makes me sad, and at this point I just need to move forward. We at least agree on that.... moving forward but I have to clear the air.
Parla
- Status
BoneSmart #1 Best Blog
Staff online
-
sistersinhimStaff member since March 20, 2017 -
EalingGranStaff member since January 23, 2024 -
Roy GardinerStaff member since February, 23, 2013
