Defective DePuy ASR XL Acetabular Hip Replacements
Thousands of People Across the United States May Be In Pain Because of Defective DePuy Hip Replacements
You or a loved one may have had a Johnson & Johnson DePuy hip replacement that was made after 2003. The problem is, many of these hip replacements have been found to be defective – which means going through the expense and the physical pain of revision surgery – not a pleasant prospect.
There are lawsuits in progress right now to get financial compensation for those who have suffered because of these faulty artificial hip replacements. You may be able to get a cash settlement too, if you’ve been affected by this recall.
It doesn’t matter where you are located – we can still represent you, or we can even help with a referral if you’re outside of Florida. Don’t wait, get help now, before the lawsuits are all filed.
What should I do now? What’s next?
If you or a loved one has had replacement hip surgery after 2003, and are still experiencing pain several months after your surgery, contact Viles and Beckman, LLC at 1 (800) 648-4537 or at 1 (239) 334-3933 or fill out the FREE CASE REVIEW form on the right side of this page.
We’ll contact you back right away to discuss your case strategy, and how we may be able to get you financial compensation for your pain and suffering.
Do you have a Du Puy hip replacement claim?
Viles and Beckman, LLC is dedicated in helping those patients who have received a DePuy Hip replacement and have suffered because of the defective hip.
Viles and Beckman, LLC handles cases from its offices in Fort Myers, Florida, and serves all of Florida. We can also refer you to an experienced DePuy Hip attorney in your area, if you do not live in Florida. Just ask, we’re here to help YOU get the just compensation you deserve.
More Information About DePuy Hip Replacement Recalls, And Revision Surgery
About the DePuy Hip Replacement
According to DePuy Orthopaedics, the manufacturer’s ASR recall website:
The patients who reported problems in the first five years and had revision surgery reported a variety of symptoms. These symptoms included pain, swelling and problems walking. These symptoms are normal if you have just had a hip replacement. If the symptoms continue or come back, it is a sign that there may be a problem.
The symptoms above might be caused by problems such as:
- Loosening – when the implant does not stay attached to the bone in the correct position
- Fracture – where the bone around the implant may have broken, and
- Dislocation – where the two parts of the implant that move against each other are no longer aligned.
The ASR Hip is made up of ball and socket components that move against each other. These metal components wear over time and generate very small particles that can only be seen with a microscope. This is an expected process. These particles do not cause problems for most patients, but a small number of patients may react to these particles, causing fluid to collect in the joint and in the muscles around the joint. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and could damage some of the muscles, bones, and nerves around the hip.
Australian Medical Journal Raises New Concerns about Metallosis in Hip Replacement Patients
On the heels of an U.S. Food and Drug Administration order to Metal-on-Metal hip replacement manufacturers to collect data on the effect of metal ions in the body, the director of Australian Orthopaedic Association National Joint Replacement Registry warns that the medical community is implanting hip devices in patients without understanding the range and nature of their adverse effects.
Dr. Stephen E. Graves wrote the editorial in The Medical Journal of Australia based on two case studies outlining the physical decline in patients implanted with recalled DePuy ASR Metal-on-Metal hip replacements and highly elevated levels of cobalt and chromium in their blood. While the reports are merely anecdotal, and the authors were careful to note that it was unclear if the adverse effects were caused by metal ions, or if the cluster of symptoms was coincidental to their presence, Graves said that these cases show that surgeons don’t know enough about the potential negative consequences of Metal-on-Metal hip replacements:
“What this and other reports have done, however, is highlight the urgent need to undertake comprehensive research to examine the relationship between high serum metal ion levels after total hip replacement and the risk of toxicity. It is critical to determine at what concentration elevated cobalt and chromium serum levels may cause toxicity, and how the extent and severity of toxicity varies with the level. This is important because surgeons currently have no information on whether a hip should be revised based simply on the patient’s serum metal ion levels. Revision surgery has significant morbidity and mortality risks and should not be undertaken without good indications to do so.”
The study, Cobalt toxicity – an emerging clinical problem in patients with metal-on-metal hip prostheses?, described patients whose wide range of physical, cognitive and neurological deficits developed over the life of their Metal-on-Metal implants, and then subsided, after those devices were replaced with ceramic and polyethylene devices.
The first patient, a 73-year-old woman had suffered “cognitive decline, memory difficulties and depression” following a stroke seven months earlier. In 2006, the patient had been implanted with a DePuy ASR XL Acetabular Hip System with a large-diameter cobalt and chromium cup, and a large modular metal head on a titanium Corail stem. Other symptoms included “a continuous metal taste in her mouth,…severe headaches, anorexia and weight loss. She had mild groin pain but otherwise no symptoms related to her hip.” Elevated chromium and cobalt levels and her pain complaints led to a total hip replacement revision in March 2011, with an all-polyethylene cemented cup and a ceramic head. Eight weeks after the revision, her serum cobalt level dropped and the pain, fatigue and metallic taste were gone. Her appetite returned and she gained weight and greater energy.
The second patient, a 60-year-old male engineering professor, suffered from painful muscle fatigue in all limbs, “feeling faint when performing simple tasks; inability to climb a flight of stairs without needing to rest; and a decline in cognitive function… His previously stable hypertension had become uncontrolled and required additional medication.” In February 2011, his hip implant was replaced with a polyethylene and ceramic device. While there was no tissue damage at the hip joint or metal debris, the patient had sustained a highly elevated serum cobalt level. Eight weeks after the revision, his serum cobalt level dropped significantly, and he reported increased energy levels, a decrease in muscle pains, improved exercise tolerance and the ability to walk without restriction.
The doctors concluded that in both cases, the pre-revision symptoms were caused by metal ions:
“We believe our patients’ symptoms were related to their elevated cobalt levels, resulting from cobalt leaching out of their hip prostheses. Both patients had metal-on-metal hip prostheses, and both patients’ cobalt levels were reduced after removal of the metal-on-metal prosthesis. We are concerned that cobalt toxicity may be under-recognized, particularly if patients consult doctors who may not be aware of the details of the patient’s hip replacement and the potential for release of cobalt into the circulation.”
Graves’ editorial pointed out a more significant problem – regulators are allowing devices to come to market without adequate vetting and without an understanding of how they fail and of the consequences to the patient:
“The global experience with the ASR system, and potentially all metal-on-metal devices, has important ramifications for arthroplasty device regulation. How is it that the ASR was approved for use? Could this situation occur again? Currently, it is not mandatory in Australia for a new hip or knee prosthesis to have clinical evidence specific to the device that indicates it is either safe or effective.”
Here in the U.S., the FDA is finally moving to gather data, but it will take years for the trends in patient outcomes to emerge. In the meantime, how many patients will be the subject of a manufacturer’s experiment?
Complaints on Unrecalled Pinnacle Hip Implants Rise Sharply
It is very difficult to determine the success or failure rates of a particular hip implant. Unlike Britain or Australia, the U.S. government does not sponsor a joint registry, in which surgeons and hospitals submit data on primary surgeries and revisions. In 2007, health care conglomerate Kaiser Permanente launched its own National Total Joint Replacement Registry to collect information about patient demographics, implant characteristics, surgical techniques, and clinical outcomes, in an effort to identify problems and best practices, contain costs and improve care.
In the U.S., revision rates may become public when a hip device is recalled. For example, DePuy revealed higher than normal revision rates for two DePuy Metal-on-Metal hip devices that the company recalled last year, the DePuy ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System. Publicly available information, however, is scant. The FDA does operate a web-accessible complaint database. Complaints related to hip devices prostheses get filed into the Manufacturer and User Facility Device Experience (MAUDE) database. MAUDE data consist of voluntary reports made to the FDA since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. It represents the only government repository of adverse event reports related to medical data. But the MAUDE data are not easily accessible to the average consumer. This is primarily because the most complaints the MAUDE will produce in an Internet search is 500, even if there are many more in the system. We examined MAUDE data from 2005 to March 2011 for reports of adverse events involving Pinnacle Metal-on-Metal systems, and the data show that adverse event reports have steadily increased since 2005.
Adverse Report Events Reported in MAUDE by Year Involving DePuy Pinnacle Systems Calendar Year Unique Reports:
|2011||119 (01/2011 – 05/2011)|
Complaints have risen sharply since 2005 – nearly quadrupling between 2008 and 2010. The narratives that accompany these adverse reports attest to the classic symptoms of defective Metal-on-Metal implants: “Patient was revised to address excessive cup ante-version resulting in dislocation. Metal debris was found in the joint.”
“Patient had to have revision hip replacement surgery to remove a Metal-on-Metal total hip implant which had caused significant synovial inflammation and metallosis reaction. The implant was a depuy pinnacle Metal-on-Metal hip replacement system -not the recalled ASR system. Dates of use: (b)(6) 2003 – (b)(6) 2010. Diagnosis or reason for use: hip arthritis. Event abated after use: yes. This is to report a significant problem with complications due to Metal-on-Metal wear particles leading to a pt necessitating revision hip surgery and removal of implants due to severe synovitis and perivascular lymphocytic infiltrate, confirmed with tissue pathology. The relevance is that this is a different product within the same company -DePuy Orthopaedics- which has recently had a different Metal-on-Metal hip implant recalled by the FDA – the ASR hip system-. This is to report a problem with their Pinnacle Metal-on-Metal system. The common factor being the Metal-on-Metal bearing, leading to metal particulate release, and significant synovial reaction, and necessitating revision surgery and implant removal. Patients should be made aware of the significant risk associated with this system.”
They also aptly describe the effect on patients:
“I had a left hip replacement (DePuy Pinnacle) on (b)(6) 2009 and ever since (b)(6) 2010 I have had a problem which keeps getting worse. I have difficulty standing still for any length of time. If I stand for 10 minutes shaving, I am in severe pain for the rest of the day. I can only sleep on my right side. I cannot sleep on my back or left side at all because the pain is too much. I cannot food shop, clothes shop or shop period because I cannot walk for any length of time. Unless my activity includes sitting such as the movies, out to dinner or the doctor’s office, I cannot go out. The quality of my life has deteriorated. I am in worse shape now then I was before I got my hip replaced.”
And yet, it’s hard to know what the revision rate is for the Pinnacle Metal-on-Metal hip system, because it has not been recalled. We suspect that it may have higher than normal revision rates, based on the representations DePuy made to the FDA when it sought approval for the ASR system. In 2005, DePuy won approval for the DePuy ASR Modular Acetabular Cup System by claiming that the design was substantially similar to the DePuy Pinnacle® Metal-on-Metal Acetabular CupLine. In January 2008, the company again sought and gained approval for another variation on the ASR metal acetabular cup, the DePuy ASRTM 300 Acetabular Cup System by claiming that the device was “substantially similar” to the DePuy Pinnacle® Acetabular Cup System.
Despite the company’s claims to the FDA that the metal acetabular cups in the ASR and Pinnacle hip systems are “substantially similar,” DePuy’s Pinnacle hip replacement has not been recalled. In the meantime, a rising number of complaints about the Pinnacle Metal-on-Metal system continue to be lodged by patients and surgeons in the MAUDE system.
Viles and Beckman, Florida personal injury attorneys, explain how DePuy hip implant recall affects Southwest Florida
FORT MYERS, Dec 1, 2010 /PRNewswire/ — Southwest Florida may be at the epicenter of a huge recall of the ASR XL Acetabular System and ASR Hip Resurfacing System. The hip replacement recall is the result of unprecedented failure rates in the DePuy product putting tens of thousands of seniors at risk for revision surgeries, pain, instability, difficulty walking and metallic particle (ion) blood contamination. “Southwestern Florida is a year round home to hundreds of thousands of seniors, and countless winter residents,” explains hip implant lawyer Michael Beckman, “and with our area’s world class orthopedic doctors and award winning hospitals, tens of thousands of seniors are walking around with hip implants, putting Southwest Florida at the very heart of the DePuy hip implant crisis.”
Southwest Florida, because of its warm climate and friendly atmosphere, is a haven for seniors and has one of the largest senior populations in the country. Consequently “Southwest Florida is going to see a lot of action when it comes to the DePuy hip implant recall – there are potentially thousands of victims,” says hip implant attorney Michael Beckman. Moreover, for those who will require a brutal “secondary surgery” to tear out the defective hip implant and replace it with a new one, “many winter residents are going to elect to take advantage of the excellent local weather, top notch doctors, and have their revision surgeries here, rather than try to go back north for the procedure,” says Beckman.
The ASR XL Acetabular System and ASR Hip Resurfacing System hip replacement recall came about because the devices were failing at unusually high rates, triggering pain, instability, revision surgery and the release of very small metallic ions into the blood.
“Winter residents may usually file claims for compensation here,” says implant lawyer Marcus Viles, especially if they have sought treatment or suffered a portion of their injury in Florida. Revision surgery victims may be entitled to medical expenses (past and future), money damages for pain and suffering, and inability to enjoy life. If you or a loved one has suffered injury from a defective hip implant you should contact Viles and Beckman or call 800-648-4537.
Viles and Beckman, LLC is a personal injury and consumer protection firm focusing on personal injury, foreclosure defense, and Darvocet claims. The firm handles cases from its offices in Fort Myers, Florida, and also serves Naples, Fort Lauderdale, Broward, Miami, and West Palm Beach.
SOURCE: DePuy Settlement Website, (article is no longer available)
DePuy Hip Replacement Recall Impacts Thousands of Florida Seniors
Viles and Beckman, Florida personal injury attorneys, now helping seniors at risk for “revision surgery”
FORT MYERS, Nov. 30, 2010 /PRNewswire/ — DePuy Orthopedics, Inc., a Johnson & Johnson subsidiary recalls the ASR XL Acetabular System (part of its hip replacement implant) and its ASR Hip Resurfacing System. These hip replacement recalls are because the hip socket and hip replacement implants are failing at an unsafe rate putting tens of thousands of seniors at risk for revision surgeries, pain, instability, difficulty walking and metallic particle (ion) blood contamination.
DePuy victims may require painful and complicated “revision surgeries” where the old implant is drilled or hammered out and a new implant is put in its place. The revision operations risk bone loss, blood clots, stroke, instability, cardiac arrest and put seniors at serious risk of crippling injury or death. “Many seniors are going question whether they really want to take a chance on another Depuy implant for their second surgery,” says hip implant attorney Marcus Viles.
“Secondary surgery” victims “may be entitled to compensation for pain and suffering, emotional distress, and for future convalescent or nursing home care,” says hip replacement attorney Michael Beckman. Person’s who have suffered pain or surgery from the ASR hip replacement system should contact Viles and Beckman, LLC or call us at 800-648-4537.
About Viles and Beckman
Viles and Beckman, LLC is a consumer personal injury firm focusing on defective medical device claims, such as the DePuy ASR XL Acetabular System Hip Replacement. The firm handles cases nationwide from its offices in Fort Myers, Florida.
SOURCE: DePuy Settlement Website, (article is no longer available)
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- How Long Do Hip Replacements Last? (earlsview.com)
- Associate Professor Michael J. Neil – Doesn’t Recommend Resurfacing (earlsview.com)
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