Question please

[Nursepair]

I heard recently that they are re calling patients with a Zimmer Gender and having to do revisions. Anyone heard anything about this please

Thanks, Sue

@Josephine:

 

[LCR]

I just had a Zimmer NexGen LTKR on January 3, 2012. Everything is going very well. I'll be curious to follow your thread.

 

[Jamie]

Where did you hear that, Sue? There is a lot of misinformation floating around about the Zimmer NextGen replacements. I've not heard of anything like that.

Is it supposed to just be something in Canada? Who would be "they" be who's doing the calling?

Not intending to grill you, of course. But we do like to check these things out thoroughly.

I'm going to put a tag in for Jo so that she sees your question quickly.

 

[Josephine]

All I could find was this

Link to FDA Notice November 13 2009
Reason for Recall: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.

Action: An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a change to the surgical technique, to include the use of a new peripheral rib impactor tool.
Please note that the recall is current 2½ years old and has been resolved.

In simple terms, surgeons have reported/complained that fitting the plastic insert into the knee, which is invariably a tight fit, was sometimes so tight there was a risk of damage to the plastic surface. Quite likely the stem of the complaint would be that, because the plastic had been damaged and therefore disposed of, at least one more new implant had to be opened adding additional cost to the procedure. It would be hypothesized that, should such a damaged insert have been used in the knee, it could have resulted in a need for early revision, which is true.

Personally I very much doubt that would ever have happened as surgeons are generally extremely vigilant about such things. Of course, there could be surgeons who sadly could not be so vigilant - even so, the need for early revision still might not be an inevitability as it would depend upon the nature and position of any damage.

As a result of this, Zimmer added a special tool to the instrument set to make this action easier as stated in the underlined text so any of these devices installed since January 2010 should be fine.

Hope this sets your mind at rest.

 

[LCR]

Nursepair, I see you had your TKR's done in 2010. Are you having problems? As I said I had a Zimmer NexGen knee done on January 3, 2012 and my recovery has been awesome. My knee swelling is minimal (unless I pull a 10 hour day!), I am straight and my gait is almost normal after 10 years! I am so happy, I can't imagine that Zimmer, as a manufacturer, wouldn't have put their engineers on the problem real quick, as the liability would have been great. My OS has a great reputation here in Pittsburgh. I trust he wouldn't have used an inferior product.

 

[Randi]

I am in Florida now and there is a commercial airing for a potential lawsuit regarding a TKR related recall. They don't mention the product name , only want you to call for a 'free' consultation. If there was a recall wouldn't they have to notify the patients ?

 

[Josephine]

Not necessarily. It depends upon the reason for the recall. Most recalls are for minor issues like variances on the specs or even packaging/labelling inconsistencies.

 

[bottomshollow]

I really wish the ambulance chasers (lawyers) would find something else to do. They spend tons in advertising on TV trying to scare the unknowing and uninformed to death. And all so they can make the big bucks while a person who may deserve recompense gets pennies.

Just before I had my hip surgery they had the big DePuy recall---didn't stop me.

Just my opinion for what it's worth. :cat-kittyandsmiley:Judy

 

[Campervan]

I had TKR 14 Dec 11 and knew about the Zimmer recall, knew my surgeon was using Zimmer product for me. Didn't stop me going ahead and I didn't even talk to surgeon about it. I knew my surgeon wouldn't use something he didn't trust.

 

[karmigirl]

Randi,

I fully agree with Campervan, any surgeon worth his salt would know about these recalls. He would be a real fool to use something he knew was faulty in any way shape or form. Besides if he did and it had to be revised think about what that would do to his reputation. I too have a Zimmer Gender specific put in June 6 2011 and I know my surgeon was extremely careful about what he was using because of other problems I may have had, no problems from me.

 

[Minnie]

September 13, 2010 — The FDA issued a Class 2 recall of the NexGen Complete Knee Solution MIS Tibial Components. In the recall notice, the FDA stated there have been:

“Complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs (Medical Device Reports) filed, all reporting that the device loosened and the patient required additional surgery to replace the device.”

More than 68,000 of these products had previously been distributed.

Prior to the recall, Zimmer Inc. sent out an ”Urgent Device Correction” letter on April 26, 2010 to all customers describing the problem and instructing them to destroy all previous versions of the surgical technique, and to review the attached revised surgical technique, which instructed surgeons to cement and pressurize the tibial component.

December 2, 2010 — The FDA issued a Class 2 recall for the Zimmer NexGen Complete Knee Solution LPS Femoral Components. The recall was issued for several different sizes of the femoral component, citing problems with a “nonconforming internal CAM radius.” The recalled components include:

Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component

Size E, left knee
Size E, right knee
Size F, right knee
Size G, left knee
NexGen Complete Knee Solution LPS Femoral Component (n.k.a. LPS Option Femoral Component)

Size E, right knee
Size F, right knee
Size F, left knee
Size G, left knee
Size G, right knee


Above are a list of Zimmer recalled components. Also 2 doctors, Berger and Vella asked Zimmer to recall their CR Flex non cemented knees citing a high incidence of loosening .. but this has NOT been done.

hope this helps. Bless you all.
Minnie

 

[Randi]

Thanks Minnie -I'm assuming that none of the recalled prostheses are being used now...since mine is on the list I sure hope not !

 

[bottomshollow]

Sure am glad I don't have a clue what brand of knees I got--didn't care when I got them, don't care now. Just as long as they do their job, I'm happy. And I don't have to worry about recalls--cause they will be meaningless to me. Judy

 

[Minnie]

They are pulled from stock but one got in me. I was the person who told my doctor it was recalled, no one told him. I don't think he was very happy.
I pray it does not happen to anyone else.

Minnie

 

[Nursepair]

Thanks everyone. I appreciate all the info. My surgeon more or less admitted once that the first TKR may have been a bit tighter than it should be, I have never got as much flexion back in that one. No other problems so far though. The 2nd one tends to give way on me on the very odd occasion, doesn't seem quite as stable but it really doesn't bother me too much. Otherwise I am very happy with them both.

We don't do law suits over in Canada as much as the US. I think I saw the article on the internet somewhere on a Canadian site, can't remember where, though it wasn't an ad or a lawyer thing as I remember.

I may bring it up with my surgeon anyway, though he usually does x rays on both knees when I see him anyway. .

Thanks again all. Have a wonderful recovery all, Sorry I was so long getting back, not been feeling well for the past 10 days. Getting better now though

(((HUGS))) Sue

 

[Jamie]

@Minnie:

It would be helpful if you could please place the links in your post where you pulled the quotes. You have obviously done a lot of research on this issue and I want to ensure that your post is adequately footnoted with the links.

I found the FDA link to the Zimmer recall in September, 2010. This link is for one of the recalled sizes and there are others. But it appears to be the information you quoted.

 

[Josephine]

Well, if you read that carefully you will see that it's not the device that's been recalled but the written surgical technique! :DOH:

Prior to the recall, Zimmer Inc. sent out an "Urgent Device Correction" letter on April 26, 2010 to all customers describing the problem and instructing them to destroy all previous versions of the surgical technique, and to review the attached revised surgical technique, which instructed surgeons to cement and pressurize the tibial component.

I've said it a million times before but I will say it again - loosening is not caused by implants but by inadequate surgical technique

 

[Minnie]

Thank you Josephine, i know you are very knowledgeable and I am new to all this knee stuff. sorry Jamie, I don't know how to do a link :DOH:

Maybe it is a coincidence my recalled knee failed? I don't want to cause trouble in any way but went I was searching for information I noticed this-- which I copied and pasted from your site. I am guessing you are not allowed to say anything cause Zimmer is your Sponsor?
It is ok, I understand business is business. You all have been real nice to me and I appreciate it.. and don't wish to cause any problems. I just was praying if I could help someone not suffer they way I did. They say the Lord works in mysterious ways and sometimes it comforts me to think my problem could lead me to help someone... so it was not all for no reason.
Blessings to you all .. it makes me sad to see some of you are in so much pain. I pray that you find help as I did.:doggieshmooze:


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[Jamie]

Minnie, please don't misunderstand my request for the links to material posted. It has nothing to do with Zimmer being a BoneSmart sponsor and your post is in no way a problem. The material you posted was factual and it was obvious it came from the FDA recall material. But....we like to have the actual links to the original statements to allow members reading your post to go to the source directly.

Here is the information to show you how to post links:

Posting a link

If you try and have problems at any time, just let Jo, me or one of the Mods know and we'll help you.

I understand that not everyone has 100% success with joint replacements. Those statistics that show a small percentage of problems are just fine until YOU fall in that percentage. Then it's a very real problem for you. We're most certainly here to support you as you work to resolve what is going on.

 

[Josephine]

I don't want to cause trouble in any way but went I was searching for information I noticed this-- which I copied and pasted from your site. I am guessing you are not allowed to say anything cause Zimmer is your Sponsor?

Absolutely not! We have many manufacturers that are sponsors of BoneSmart and they all do so on the strict understanding that this site and forum is not and will not express bias in any way whatsoever. I am neither muzzled by nor a mouthpiece for any firm and I say it as it is. Always have done and always will. And the owners and sponsors of BoneSmart are completely supportive of that.

Maybe it is a coincidence my recalled knee failed?

Not quite sure what you mean by this.

Facts are these
In the long term, implants can loosen be they knees or hips. It happens. Some replacements last for donkey's years and some don't.
However, in the short term, loosening is always due to the cement not being embedded into the bone properly. This has been known about for decades. Over the years, surgical technique has been refined to include certain techniques to make sure the cement is forced into the matrix of the bone so it doesn't easily loosen.

This has nothing to do with the design or manufacture of the implant and that is true no matter which manufacturer marketed them. They are all prey to this if the cement insertion technique is inadequate.

It would be the same as if you had a house built or an extension and the builder didn't lay the bricks and mortar properly. Eventually the wall would fall down. It's not the fault of the bricks or the mortar, it's the fault of the builder. You see what I am saying?

And if you still don't quite understand what I mean, have a look here Cemented and uncemented hips - I know it's about hips but the info about cement applies equally to knees or any of the other many joints that can be replaced.