Hip Replacement Recall By Depuy Orthopaedics Is Big News
Editor's ChoiceMain Category: Bones / Orthopedics
Also Included In: Medical Devices / Diagnostics
Article Date: 31 Aug 2010 - 11:00 PDT
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'Hip Replacement Recall By Depuy Orthopaedics Is Big News'
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Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England and Wales, the manufacturer announced this week it is voluntarily pulling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System from the marketplace. DePuy has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally of the voluntary recall.
The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices preferred by surgeons for young patients who may benefit from the stability of the device, thus limiting the chance of repeated dislocation. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.
The risk for revision was highest with women utilizing ASR head sizes below 50 mm in diameter.
As the numbers suggest, most ASR hip replacement surgeries are successful. However, Depuy is strongly suggesting patients utilizing an ASR device immediately see their implant surgeons for a full evaluation of performance.
President of DePuy Orthopaedics David Floyd released this statement:
We regret that this recall will be concerning for patients, their family members and surgeons. We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.
DePuy will cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.
Patients and health care professionals with questions related to this recall should visit depuy.com. As of August 27, patients in the U.S. and Canada can contact DePuy by calling 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients in other countries can place a collect call to the U.S. at +1 813-287-1651 24 hours a day, seven days a week.
It is interesting to note that DePuy decided in 2009 that it would be discontinuing the ASR System because of declining demand and the obvious need to focus on modern replacement and resurfacing emerging technologies.
Written by Sy Kraft (B.A. Bachelor of Arts - Journalism - University of California, Santa Barbara or California State University, Northridge)
Copyright: Medical News Today
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Visitor Opinions (latest shown first)
Recall
posted by Donna Cole on 24 May 2012 at 7:04 amI feel sorry for those who are affected by these failed devices.
Another Recall
posted by carol on 27 Apr 2012 at 12:46 pmFYI DePuy recently had another recall in parts of Europe, Australia and New Zealand, this time its the MITCH THR system
Re: Leanne - Hip replacement recall
posted by Rebecca on 27 Jul 2011 at 12:59 pmLeanne,
Metal poisoning is a complication that afflicts people who have the metal on metal hip implants (where the ball and socket meet). They are pretty notorious for popping out and also creating this metallic dust which poisons people.
You want to find out what model and manufacturer of hip implants you have.
In all likelyhood (f you were to have metal poisoning) it could be a DePuy ASR:
DePuy hip metal poisoning: http://depuyhiprecall-info.com/depuy-hip-complications/metal-poisoning/
How do I know if i am at risk?
posted by Leanne on 14 Mar 2011 at 11:07 pmI was born in 1964 and was 3mtns premature, thus sending in a priest to my mother telling her I wouldn’t live. As you can see, I did survive and when I was two my mother noticed I still had a bruise across my lower back, which the doctors said was normal. I should have been thoroughly checked seeing as I did not die, but they neglected to do so. My mother then took me to our local doctor in town and he sent me to a hospital close by for x-rays, which showed I had congenital dislocation of both hips.
I was sent down to The Royal Children's Hospital in Camperdown, Sydney. There I stayed for nearly 2years in a full body cast. I was then placed in calipers to straighten my legs, but to no avail, my bones had already developed a certain way. When I was 19yrs old I had a pelvic osteotomy to help me cope with the pain and to prevent me from having a total hip replacement so young. It had helped me somewhat, I still had a lot of pain, but tried to live a normal life like any other teenager.
My hips would pop out every now and then, but I knew how to put them back in, not to say how extremely painful it was. Anyway, my right hip came out one day in 2004 while taking my shoes and socks off and nothing could stop the amount of pain I was in. I was sent to our local hospital where I stayed for nearly 9wks prior to surgery. I was operated on the 2nd Aug, 2004, I had a total hip replacement and still have pain in that hip to this day. My left total hip replacement was done on the 19th Oct 2010.
I go to hydrotherapy twice a week and try to walk, but cannot walk around the streets without aid. I now have a major fear of stairs, falling and travelling on public transport. My concern now is if Cobalt and chromium were used in the implants used and how I can find out? I am now 47yrs old and feel as though my life is completely stuffed up.
I suffer from sciatica, which is excruciating pain that travels down both legs. I am guttered, as my life has changed for the worse not for the better. Please, I’m pleading for help and am sick of having to live on painkillers daily. I am trying to get my medical records from the hospitals where the surgery took place. I know I’m not the only one, but I truly hope you can give me some answers and sorry to say this, but maybe compensation for one of the largest and most severe medical stuff ups I've had to witness.
Regards,
Leanne (from Australia)
Writer with law firm
posted by Taylor Lindstrom on 28 Nov 2010 at 8:56 amMr. McCready,
I've been helping write informative articles on the DePuy hip replacement case over the last few months for law firm Moriarty Leyendecker. While I'm not a doctor, to the best of my knowledge the "anterior approach" is actually a method of conducting the surgery, rather than a model of implant. It is my understanding that any implant may be placed using any of the possible surgical techniques, including posterior, lateral, antero-lateral, and anterior. There is also a minimally invasive approach, which may have some limitations on what kind of implant can be placed.
The different approaches are merely different incisions to gain access to the area where the implant will be placed. I believe that with the anterior approach, you would be able to have any kind of hip implant. It is probably best in any case to consult your doctor - or your medical records - to determine whether you have a DePuy ASR Acetabular system.
Again, I'm not a doctor and this is only my information that I've garnered through my research. I would highly recommend talking to your doctor. If it turns out you have an ASR Acetabular system, I'd like to invite you to contact Jim Moriarty, the senior partner at the firm, directly. He would be able to tell you if you have a legal case against DePuy.
http://www.moriarty.com/depuy_hip_recall/
Patient
posted by L Stephen McCready on 23 Oct 2010 at 4:47 pmIt would be helpful if some more common details were provided. For instance, I know I had anterior surgery. Is this device a traditional or anterior model? Simple enough.
6 Hip Implant Recall Things to Know
posted by Nagelberg on 16 Sep 2010 at 4:20 pmCrucial information on what steps to take if you are affected by the ASR Hip Implant Recall.
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