Lounge Doctor

Zimmer Durom Cup Issue

Status
Not open for further replies.
D

dcdowden

junior member
Joined
Jul 21, 2008
Messages
80
Location
United States
I went to my OS today for my 7 week check up on my right hip and I heard something that is a little scary. The Zimmer company has stopped providing their Durom Acetabular Cup to surgeons in the US until they provide additional training to all the surgeons. What is scary for me is I now have two of these Durom Cups - one now 5 months post surgery and the other 7 weeks. Both hips seem to be going well and the OS says the XRays look great. Apparently, there is a higher revision rate (over 5%) with these implants with some clinics and surgeons in the US than for others. For some reason, this does not seem to be an issue in Europe. Here is a link to some background info on the Zimmer web site.
https://www.zimmer.com/web/enUS/pdf/Durom_Backgrounder_on_Status_7-22-081.pdf
If you google Zimmer Durom now, you can see that the lawyers seem to be all over this.

I figure I still have a better than 90% chance of not having these problems with my new hips, but it certainly does give me pause.

Doug
 
Hello All: I'd like to add information about the Zimmer Durom Cup and resurfacing. There are several resurfacing systems in wide use in the United States and abroad, Zimmer Durom being only one of them. I personally have the Conserve Plus system, which is manufactured by Wright Medical Company. In wide use in Europe is the Birmingham Hip Resurfacing System. Also widely used in both the United States and abroad are the Biomet System and the Corin System. These component systems all have very good track records so far. The only one that does not is the Zimmer Durom.

Take good care all,
Ruth Z
 
Actually the implant that was having problems was reported by Dr. Larry Dorr and he only does THR's, he does not even do resurfacing. He sent a letter out to all the orthos that are members of the AAOS warning them of the problem. There are very few Zimmer resurfacings that have ever been done. The most widely used resurfacing device is a BHR from Smith & Nephew, then also the Biomet and C+. The only two approved by the FDA are the Stryker Corin and the S&N BHR. Here's a link that shows it is the THR component, although some (very few) resurfacing devices are involved as well, the most that had problems were the THR device.

https://www.nytimes.com/2008/07/29/...cp=2&sq=zimmer&st=cse&oref=slogin&oref=slogin

Vicky
 
I would like to understand where and when the Durom cup was used. I called my surgeon's office immediately after seeing the New York Times article and immediately talked to a nurse who told me that the Durom Cup was used only in resurfacing and not in THR used by my surgeon. But I read here and on the web that it might be used in THR so I am confused. Does anyone know how to find what system was used without directly asking your surgeon who may or may not want to tell you about the Durom cup?
 
Hello Jmags:

I can understand your concern about the Zimmer Durom cup. In your surgical report, there should be a reference to the type of prosthesis you have. That report is something you can confidently ask for as it should be a part of your own health records. I was not given my surgical report when I left the hospital (some other people report they were given their's) so I just called my surgeon's office nurse, and she mailed it out to me right away.

To my understanding, a hip implant prosthesis comes as a "matched set" ie. as in my case, I have both the Conserve Plus resurfacing acetabular cup and femoral component in each hip.

Also, there is still some confusion about whether the Zimmer cup is used in resurfacing (which as Vickymm pointed out in her post that it is not, according to the letter from Dr. Dorr) or just in thr's.

I imagine one could see a copy of that letter, or at least get the details. Maybe Vickymm can respond?

Take good care,
Ruth Z
bilateral resurfacing 4/6/06
 
Hi Jmags,

I actually have a copy of the letter that circulated to all the doctors from Dr. Lawrence (Larry) Dorr on my home computer. I can look for it tonight when I get home from work and send you a copy of it via private email. I know for a fact it was definitely a THR component that he was referring to only because Dr. Dorr does not do hip resurfacing. Now the cup that was involved from what I understand was also used for some hip resurfacings. The cups for all resurfacing devices always also have a matching component for a THR device in case you need a revision down the road. But the letter that started the whole recall process was directly referring to THR devices.

Now do NOT be concerned because there are many THR devices out there. Do you know if your doctor even uses Durom as an implant? Ruth made an excellent suggestion to ask for your surgical report and in it, it should list the implant that was used. But even if your surgeon did implant a Durom device in you, from what I understand it does not always result in a problem. If your surgeon is very skilled and he seated the cup properly, then you shouldn't have a problem with it, but I am no medical expert so I am only giving you my opinion and information that I have read. I would go into your doctors office and ask them for a copy of your surgical report. They will need you to physically go in and sign a release form before they will give it to you. Unfortunately with all the strict HIPAA laws they will not allow you to fax in a request, you need to do it in person. Feel free to contact me offline as well if you would like.

Vicky
 
Here's the letter

"April 22, 2008
To: All AAHKS Members
From: Larry Dorr, MD

This NOTICE is to inform you that we have had ten revisions in 165 hips and have four more that need to be revised using the Durom cup (Zimmer, Inc). This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a
short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions.

We have notified Zimmer. The FDA has been notified and we will notify them of our continued revisions. The company does not believe it should pull the cup from the market so I am notifying all of my colleagues of our failure rate with this cup. I went through a similar scenario with the Sulzer cup failures where I was the only one experiencing revisions at the beginning and basically it was assumed that it was our technique. I can assure you that this goes beyond technique. I learned my lesson in not informing everyone about this magnitude of failures with the Sulzer cup problem, so it is my obligation to do so with this cup. If you have any questions, do not hesitate to contact me.

Sincerely,

Larry Dorr, MD"

Vicky
 
In the US, the Durom Cup was only used in THR - not resurfacing. I believe it was only used as part of a Zimmer Large Diameter Head Metal on Metal hip. Here is a link to the Zimmer web site which explains this type of hip.

https://www.zimmer.com/z/ctl/op/global/action/1/id/9962/template/MP/prcat/M2/prod/y

My surgeon originally suggested it for me because I am somewhat younger (age 56) and it was thought to have greater longevity because of the metal on metal articulation, and greater range of motion with less chance of dislocation because of the large diameter head. My surgeon said that some insurance companies would not even pay for it for people over 50, but mine would. He also told me before my first THR in March, that he could not guarantee that he would be able to use it until he operated and tried it out. Apparently, he already knew that inserting the Cup was more challenging in some cases. My first question after waking up from the surgery was whether he was able to put in the Large Diameter Head Metal on Metal implant. He was also able to place the same implant for my second THR in June, but again he said before hand that he would have to make sure that it would be good at the time of surgery. Hopefully, my surgeon's caution about making sure the cup was well seated during surgery is a good sign for me. So far, both hips are doing well.

You certainly should ask your surgeon what device they implanted including not only the cup, but also the type of ball and stem in your femur. My surgeon said that his group uses Zimmer products and typically you would get a ceramic ball and plastic (with fancy name) lined cup (not the Durom cup) unless you specifically talked about something different. He also said that the Large Diameter Head Metal on Metal hip was the 'Mercedes' of implants which the hospitals and insurance companies did not necessarily like from a cost standpoint.

Doug
 
Hi Doug:

Thanks for sharing this information with others having questions about the Zimmer Durom Cup. The link is great!

You brought two items to light that I was not aware of: 1)some insurance companies are not willing to pay for the large ball MOM hip implants and 2)not all surgeons feel comfortable giving certain patients the implant because of size considerations. Could you elaborate on this last point? I am very small, 4'11" and weigh less than 100 lbs. My implants came in a wide variety of sizes and I thought pretty much all implant types had several sizes as well.

It is because of people such as yourself, on boards like this, sharing their experiences and the information they have found that people can become their own best patient advocates. I know when I was doing my research about hip surgery options, I was so fortunate to connect with people who were willing to help me in my quest for what was right for me.

I ultimately got bilateral resurfacing and am very glad I was able to do so. Take good care Doug, and thanks again.

Happy dancing,
Ruth Z
bilateral hip resurfacing 4/6/06
 
Just visited my OS today - it has been almost 11 weeks post surgery now. He said the x-ray looked good and I am doing well. I am starting to walk some without the cane around the house and the hip feels good. I still have some pain along the IT band which I seemed to pull a couple weeks ago in PT, but it is getting better. PT is over, and I am trying to work on building strength through walking. My OS said it is OK to get back on the recumbent bike even though I will go past 90 degrees because of my height. He said the metal on metal large diameter head (LDH) implant should give me good range of motion with very low risk of dislocation. My OS said that Zimmer has put out new on-line training for the surgeons and that his group has started to use the Durom cup again for metal on metal LDH implants. He said that he has a couple surgeries in the next week where they plan to use them including one for a cardiologist. I am starting to do things I haven't been able to do in a couple years, so I feel real good about that. Now if I can only build up the strength in my right knee again and avoid any more surgeries for the torn meniscus in there, I'll be really happy.
Doug
 
Excellent! I'm really pleased for you, Doug.
 
I spoke with my surgeon before the surgery and he assured me that the Zimmer hip was the best one for me. I told him that I knew of the Zimmer problems. So now, I have my hip.

I am returning to work on Monday!! I hope for the best with my Zimmer. In my career, I'll be the best test for the durability of this thing. Onward and upward!!
 
All the best on your return to work, Jessie. Mind you don't go and over do it though!
 
At least I work for an ambulance company. I'll be on light duty only for a while. I don't think anyone around me will let me overdo anything. It'll be great to be around people again.
 
I have had both hips done this last year with Large Head Metal on Metal Zimmers. I have the cup in question. The first one was fantastic and I walked out of the hospital on day 2 with just a cane. The second was not the same. When I first stood up i could tell something was very different. I couldn't get into bed for 2 weeks. I have never been able to stand on this leg and have felt like I still had my old hip pain. Spent most of the year in therapy and massage. The other day my doctor discovered radiolucent lines around the cup. He wants to do a revision and change the cup and ball to a smaller ball 28mm and a highly cross linked polyethylene insert. I was hoping to go many years on this and avoid all the bone issues with the plastics. I am 50 and have an active job. Has anyone had to deal with this and what parts did they use to fix it. Zimmer makes a plastic cup that accepts a ball as large as 44mm but not yet sure the doc wants to do this. If a replacement was due out so for metal on metal I would wait it out even though the pain is about a 6.
 
Antnee, what a shame you had this experience. You have my sympathies.

The only bit of comfort and encouragement I can offer is that there are many, many thousands of people world wide who have metal on plastic and have had no problems with them. Over the years, it has been the standard for hip replacements. To my knowledge, the incidence of the issues you mention is actually very low. Much lower, actually, than the problems with the ceramic prostheses.
 
Thanks. Like some others I have been dealing with the hip issues for a long time. Because of my age the doctors always wanted me to wait. I had development dysplasia and they have been pretty painful for the last fifteen years. The docs always cited osteolysis as a concern with plastic. Hopefully the newest stuff won't be an issue.

Thanks
 
Antnee, my understanding is that the zimmer hip is not a problem. The problem is with the installation. I don't know of a problem with this hip outside the US. Not sure the reason. The hip was not recalled. They stopped selling them (in the US only?). I feel pretty comfortable with my decision to go ahead with this hip. Ask me again in a month when I'm still not back on my ambulance. Do a little research on your own, maybe even ask for a second opinion from another OS (regarding just swapping the cup) I guess I'd do just about anything to keep me from having to completely switch my hip out, but that's just the chicken in me talking. I wish you the best.

By the way, you said you have an active job. I'm a 48 year old Paramedic (on light duty and hating it).
 
Jessie

Police Officer - light duty

It seems there is a difference between the Euro cup and ours. The thickness of the coating that the bone is supposed to attach to is thicker in the US.

Dr. Dorr, who made this issue known, is a consultant for Zimmer and he has stopped using it before Zimmer withdrew it from the market.

Unfortunatley both of mine after the information made it to Zimmer. So far one of them is okay. It will be two years in May. The other, which was a year last month has always been painful and lacking in range of motion.

It just takes a while to recover from the surgery to realize where the pain and weakness are coming from.

On a side note - All the pain drugs, from the morphine drip to the pills, oxycodone, oxycontin, hydromorphine, and vicadon seem useless. The only one that actually helped was Talwin. After two doses of Talwin I was feeling bugs crawl on me and discontinued it. Anyone else with this reaction or anyone know of a different drug that I can ask for. My surgeon is stumped on this and this is the part I am dreading next month.
 
Status
Not open for further replies.
Active Antibacterial

BoneSmart #1 Best Blog

The Best Total Knee Replacement Blogs of 2020

Members online

Total: 284 (members: 5, guests: 279)

Latest posts

Back
Top Bottom