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Author Topic: ASR Recall by DePuy  (Read 7468 times)

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Pat Walter

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ASR Recall by DePuy
« on: August 31, 2010, 02:10:22 PM »
DePuy has announced that it is voluntarily recalling the ASR™ XL Acetabular Head System and DePuy ASR™ Hip Resurfacing System.

Visitors are also invited to visit the DePuy website at www.depuy.com
 
*DePuy makes patient safety and health a top priority and is continually evaluating data about its products. Most ASR hip replacement surgeries have been successful. However, data recently received by the company shows that more people than expected who received the ASR hip experienced pain and other symptoms that lead to a second hip replacement surgery, called a revision surgery.
 
*For this reason, DePuy Orthopaedics is recalling its ASR™ XL Acetabular Head System and DePuy ASR™ Hip Resurfacing System. This recall means additional testing and monitoring may be necessary in hip replacement patients.  In some cases, patients may need additional surgery.

*DePuy is working closely with health care professionals worldwide to contact patients with ASR hip implants.  Most people with ASR Hip System implants do not experience problems, but it is important that patients with ASR Hip System implants be evaluated with by a surgeon. Patients with problems reported different symptoms with their ASR hip implant, including pain, swelling, and problems walking.  

DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.
 
To read more visit:

« Last Edit: January 13, 2011, 02:05:41 PM by Pat Walter »
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wayne-0

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Re: ASR Recall by DePuy
« Reply #1 on: September 01, 2010, 04:37:08 AM »
Wow, just got done reading all the info on the Depuy ASR and its recall and I'm just sitting here thinking 'oh great'. I actually have been following this for several months now because lucky me I have two ASR implants. I have talked to my Doc about this and we will stay on top of things to make sure all is well. I am coming up on my 2 yr post op Nov 7th and I'm glad to report so far all is fantastic and has been since I awoke in the recovery room ;D ;D ;D .  As far as my activity levels go I am charging as hard as ever and plan to continue as long as the body and mind allow. All with no pain so far. I have been surfing , windsurfing, skateboarding (mellow), rollerblading, iceskating, wakeboarding, wakesurfing, running, trampoline, hiking, biking, baseball, golfing, yoga  since my surgery and happy to report no problems or pain associated with any of these activities. I believe I have a great Doc who did my surgery, all at the correct angles and proper placements and so on, so I will just rest assured that all will continue to go well.  Time will only tell. That said, Bill lets surf tomorrow after work, you in?

Wayne
11-7-08  Bilat/Dr.Ball/ASR

wayne-0

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Re: ASR Recall by DePuy
« Reply #2 on: September 01, 2010, 04:40:16 AM »
OOPS    Almost forgot snowboarding also.

Wayne
11-7-08  Bilat/Dr.Ball/ASR

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Re: ASR Recall by DePuy
« Reply #3 on: September 01, 2010, 07:24:44 AM »
In.   

obxpelican

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Re: ASR Recall by DePuy
« Reply #4 on: September 01, 2010, 09:44:48 PM »
Wayne,

I would not get too concerned, you're doing well, your implants are doing their job, they got recalled but that does not mean they have a 100% failure record, you may end up being buried with your ASRs after living a VERY long life.

Chuck


Wow, just got done reading all the info on the Depuy ASR and its recall and I'm just sitting here thinking 'oh great'. I actually have been following this for several months now because lucky me I have two ASR implants. I have talked to my Doc about this and we will stay on top of things to make sure all is well. I am coming up on my 2 yr post op Nov 7th and I'm glad to report so far all is fantastic and has been since I awoke in the recovery room ;D ;D ;D .  As far as my activity levels go I am charging as hard as ever and plan to continue as long as the body and mind allow. All with no pain so far. I have been surfing , windsurfing, skateboarding (mellow), rollerblading, iceskating, wakeboarding, wakesurfing, running, trampoline, hiking, biking, baseball, golfing, yoga  since my surgery and happy to report no problems or pain associated with any of these activities. I believe I have a great Doc who did my surgery, all at the correct angles and proper placements and so on, so I will just rest assured that all will continue to go well.  Time will only tell. That said, Bill lets surf tomorrow after work, you in?

Wayne
Chuck
RH/Biomet U/C Dr. Gross/Lee Webb
8-6-08

Tommy

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Re: ASR Recall by DePuy
« Reply #5 on: September 01, 2010, 10:39:19 PM »
Don't get out much do you ;D  just call me jealous.
                                              Tommy
           
Dr Tupper  LBHR  6/02/09
Oklahoma

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Re: ASR Recall by DePuy
« Reply #6 on: September 02, 2010, 12:11:00 AM »

DirkV

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Re: ASR Recall by DePuy
« Reply #7 on: September 02, 2010, 01:32:08 AM »
Hi all,
Like Wayne-O I have 2 ASRs, and I am also a Dr. Ball patient. I had my 2 yr checkup (actually at 2 1/2 yrs) just a couple days before the recall announcement, but like Wayne says, there's not much new in terms of patient concerns. And I did spend a lot of time discussing the known issues.
I still get the impression that, when properly placed, the tighter clearance of ASR still provides the design benefits that are intended. It's just that there is less margin for placement angle error.
I imagine a black market of ASRs that can only be used by select surgeons  :)
Let me add another voice of an ASR patient who is very active and not experiencing any negative symptoms.
Keep lookin' up - on the positive side, if i ever wear out these hips (playing hockey again, hike to bottom of Grand Canyon scheduled next month, riding bike, etc.) maybe the next replacement will be covered under recall.
Seriously, I brought up activity level with the Dr. (e.g.,  I did the math on riding bike 10hr / week at avg pedal cadence of 85 rpm =~ 50k pedal strokes / wk = 2,600,000 per year). I  asked the Dr. if I might be better advised to take up gardening or something, and I really liked the reply. To paraphrase it was, ' you got this surgery to regain an active life. Your prosthetics are looking fine. keep ripping it up!'
-Dirk
Bilateral 02/08, 03/08, Dr. Ball

sroberts

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Re: ASR Recall by DePuy
« Reply #8 on: September 02, 2010, 03:11:07 AM »
Hey Dirk,

Mt Lemmon is calling you!



spencer

wayne-0

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Re: ASR Recall by DePuy
« Reply #9 on: September 02, 2010, 05:05:42 AM »
Thanks for the reassurance guys, it helps alot. I talked to Bill today and told him the 5 yr revision rate is 13% and Bill's reply was "well that means your 87% not likely to get a revision". That put it all in perspective. Thanks again everyone for the support.

Wayne
11-7-08  Bilat/Dr.Ball/ASR

DirkV

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Re: ASR Recall by DePuy
« Reply #10 on: September 03, 2010, 03:16:06 AM »
Hi Wayne, I'd also like to think that the 87% is the entire population of ASR recipients. We have the benefit of having a good surgeon (well placed devices) and being near optimal patients.

Hi Spencer, How did you know that Mt Lemmon is calling? If you are willing to hang back with me, it would be great to do that again. I'll send email and we'll see what we can figure out. I wonder if there are any other hippies in the general area who would want to go?
I love recovery training days. Had an ez day today and my mind started to wander about adapting the poem by Yeats (Lake Isle of Innisfree http://www.bartleby.com/103/44.html) to your line about Mt Lemmon calling.
I will arise and go now, and go to Tucson,   
And Mount Lemmon climb there, to see the world below;   
......
...... 
I will arise and go now, for always night and day   
I hear Mount Lemmon calling me once more   
While I ride on urban roadways, on pavements hot and gray,   
I hear it in the deep heart's core.

*****************
Well, it helped pass the time during an easy ride  :) See ya soon,

-Dirk


Bilateral 02/08, 03/08, Dr. Ball

EdK

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Re: ASR Recall by DePuy
« Reply #11 on: September 07, 2010, 12:49:24 PM »
my wife has two ASRs, done about a year apart, 08 & 09, by Dr. Bose, who chose the ASR for her based on the smaller stem sizes offered in the ASR, which he preferred for smaller people (e.g. women). based on my findings, it appears the higher failure rate is in the smaller sizes, e.g. in women, but we have much faith in Dr. Bose's skill & experience in choosing & installing the ASRs.

however, this recall is obviously not welcome news. we have an email into Dr. Bose and are awaiting his reply regarding what steps we should take. we will also call the DePuy hotline (we just found out about the recall). if anyone finds out more information, or can provide details regarding what this means regarding revisions, etc., it would be appreciated if you could post it here.

thanks,

ed

Pat Walter

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Re: ASR Recall by DePuy
« Reply #12 on: September 07, 2010, 07:21:16 PM »
Hi Ed

When the ASR was placed by the expeirnced surgeons, there were not any problems.  Dr. Bose is one of the best in the world.  If your wife is having no problems or pain, I would not be worried.  If she had problems, then you would want to get a blood test to check her metal ion level.  Please realize there were a lot of less experinced surgeons placing hip resurfacing devices.  Those are the surgeons where many of the problems arise both with the ASR and other devices.

Pat
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bkcamp

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Re: ASR Recall by DePuy
« Reply #13 on: September 11, 2010, 09:44:13 PM »
"However, this recall is obviously not welcome news. we have an email into Dr. Bose and are awaiting his reply regarding what steps we should take. we will also call the DePuy hotline (we just found out about the recall). if anyone finds out more information, or can provide details regarding what this means regarding revisions, etc., it would be appreciated if you could post it here."  Ed K

Hi Ed,
I have a 7-month old ASR by Dr. Bose, too, and am awaiting his recommendations, especially in light of the fact that I have some new positional pain.  I called the DePuy hotline at (888)627-2677 today and was given a claim number; apparently an adjuster is to get in touch with me shortly.  DePuy is encouraging all ASR patients, whether or not they are symptomatic, to consult with their surgeons about further diagnostics/treatment that may be indicated.  To my surprise, I was advised that I could forward receipts of the original surgery and related costs (transportation to India, etc.), for which compensation would be considered.
Barb
RASR, 2/18/10, Dr. Bose

EdK

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Re: ASR Recall by DePuy
« Reply #14 on: September 12, 2010, 07:26:57 PM »
Barb & Pat,

thanks for your posts. my wife has spoken with two folks at DePuy, and we're to have more conversations with them this coming week. it seems my wife was the first they'd heard from who had received the ASR resurfacing system in India, and they evidently needed to do some further research. perhaps Barb's call came subsequently and resulted in the claim number and the comp consideration offer. that's good news.

we sent an email to Dr. Bose last Sunday and haven't heard back from him yet. we know he's very busy but had hoped to receive at least an initial reply as to what steps to take locally, since that is what DePuy is recommending (i.e. contacting our surgeon). again, if anyone hears anything it's greatly appreciated if you'd share it here. also, my email is posted on my profile (click on my handle "EdK"), so feel free to contact me directly via email as well. as always, we're extremely grateful for Pat's site where so much information and personal experience can be shared.
« Last Edit: September 12, 2010, 07:29:26 PM by EdK »

pilgeram

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Re: ASR Recall by DePuy
« Reply #15 on: September 24, 2010, 04:17:26 PM »
Hi All,

I also just found out that my hip resurface was done using the recalled DePuy model.  My replacement was done in January 2008.  My resurfacing has been awesome.  sometimes, my hip is a little achy when the weather is going to change (getting older sucks).   Since my resurface, I do limit my tennis to 3 hours a day.

100 (0.1%) of the recalled hips (resurfacing and thr) were done in Bozeman, MT (population 65,000) by Dr. Gannon.  He has actually done quite alot of work to evaluate J and J products).  They have had minimal issues with the DePuy products  confirming that the skill and experience of the surgeon is key to the success of the implant or resurfacing.

Dr. Gannon sent a notice of the recall last week.  I had to go in for xrays which he will evaluate and then we will form an action plan.  It may just be yearly monitoring.  The recall letter was amazing.  In past, recall notices have addresses a minor function of my car not an integral part of my body.

Alice

Pat Walter

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Re: ASR Recall by DePuy
« Reply #16 on: September 24, 2010, 06:44:51 PM »
Alice

A large amount of people of ASRs which are working great.  Again, it depends on the placement by the surgeon.  It is good that you will get yearly check-ups, but if you not have had problems, I would not worry.

Thanks for your post.

Pat
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larry2458

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Re: ASR Recall by DePuy
« Reply #17 on: September 25, 2010, 08:47:39 AM »
i went for my 2 year check up yesterday.the x-ray looked great and my doctor said the same but he then said the hospital (wrightington, lancashire)weren't doing any more of these type of operations as the success rate was only 70%.
i didn't know whether he meant the birmingham mid-head that i had or the birmingham in general as when he mentioned not doing the ops i didn't hear much else.he asked me if i'd had any pain and when i said no he said ok then ????
has anybody heard anything similar about the mid-head device ??
larry
lbmh 16th october 2008

Pat Walter

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Re: ASR Recall by DePuy
« Reply #18 on: September 25, 2010, 11:47:25 AM »
Larry

The BHR  Birmingham Hip Resurfacing Device still has a retention rate of 96% based on the National Registries and medical studies.  There has been a lot of negative press about hip resurfacing in general and many surgeons becoming much more careful about the surgery since they need to be very skilled to do a really good job.  So many surgeons and some hospital are no longer doing resurfacing.  The BHR is still being used and has not had any problems as a device.  The retention rate use to be 99% worldwide before the US surgeons started doing resurfacing.  The learning curve is steep and the US surgeons dropped the sucess rate.  So the lesson is always use only the really experinced surgeons to prevent any possible problems. 

Here is Mr. McMinns videos discussion the BHR and negative press http://www.surfacehippy.info/mcminnnegativepr.php

and Dr. Gross discussion metal ions  http://www.surfacehippy.info/adversewearmomgross.php

There has not been any studies that I can find or know of about the BHMR  yet.  Not many doctors are placing the device.  The few that are using it are the best in the world like Mr. McMinn, Dr. Bose of India and other UK surgeons.

Pat
Webmaster/Owner of Surface Hippy
3/15/06 LBHR De Smet

ptaylor

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Re: ASR Recall by DePuy
« Reply #19 on: September 27, 2010, 08:29:41 PM »
hi pat
i had a rbhr on 1st april and am due to go in for a left bhr this friday! i happened to be talking to a friend who is a surgeon and he said i should ask some serious questions before going in re the effects of metal ions on the tissue and joint. he suggested i investigated this as much as possible in the very short time ive got and i have read an article which shows there are concerns within the profession. the article has been issued by the medical and healthcare products regulatory agency in the uk. i would appreciate hearing your views on any up to date information as soon as possible
thanks
phil

 

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