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DePuy Orthopaedics Voluntarily Recalls ASR™ Hip System

Warsaw, IN (August 26, 2010) – DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called a revision surgery. 

The majority of ASR hip replacement surgeries have been successful.  However, the company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly monitoring is recommended to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.

New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12% for the ASR™ Hip Resurfacing System and approximately 13% for the ASR™ XL Acetabular System.  These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients.  Previous post-market surveillance data from a variety of sources – including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports – had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.

“We regret that this recall will be concerning for patients, their family members and surgeons,” said David Floyd, president, DePuy Orthopaedics.  “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 intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.

DePuy is providing hospitals, surgeons and patients with comprehensive information about the recall to help them determine next steps. 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.

The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery.  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. 

Very few devices remain on the worldwide market.  DePuy decided in 2009 that it would be discontinuing the ASR System as a result of declining demand and the intention to focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.

DePuy has notified the U.S. Food and Drug Administration and other regulatory agencies globally of the voluntary recall.

DePuy Orthopedics recalls ASR hip implants

August 26, 2010

DePuy Orthopedics pulls its ASR XL acetabular hip replacement and resurfacing system off the market due to a high rate of revision surgeries.

DePuy Orthopaedics Inc. is voluntarily recalling its ASR hip replacement system after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.

The Warsaw, Ind.-based Johnson & Johnson (NYSE:JNJ) subsidiary is pulling its ASR XL Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a press release.
"New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System," according to the release. "These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients."

DePuy said prior post-market evaluations showed lower revision rates and that "the ASR hip was performing in line with other devices in its class." President David Floyd said the orthopedics division will pay for doctor visits, tests and procedures associated with the recall," including revision surgeries associated with the recall.

The company is setting up a phone line for patients and healthcare providers to handle inquiries about the recall at (888) 627-2677, starting Aug. 27. The resurfacing system is not cleared in the U.S., but overseas patients treated with the system can call +1-813-287-1651, starting tomorrow.

Lawsuits over the ASR implant are piling up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. DePuy, which introduced the ASR in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits.
DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a "higher-than-expected" failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.

The ASR isn't the only DePuy hip product with problems. The FDA warned the company this week, saying it lacks clearance or approval to market its TruMatch Personalized Solutions System in the U.S. The warning letter also accused DePuy of improperly marketing its Corail hip system.

"Promotion of this device for osseointegration (a.k.a. osteointegration), whether explicitly or implicitly (for example, through fixation claims that imply osseointegration), represent a major change or modification in the intended use of your device that require a new premarket notification," according to the letter.

The federal watchdog agency warned Biomet Inc. last week about its personalized knee implant offering, also saying the Warsaw, Ind.-based firm lacks approval or clearance to sell the device in the U.S.

DePuy Orthopaedics Metal Hip Replacement Recall

DePuy Orthopaedics recently announced it was withdrawing the DePuy ASR hip replacement following approximately 300 complaints from people undergoing hip replacement. The ASR hip replacement is a metal-on-metal device believed to have a design flaw that has resulted in many patients needing follow-up operations to replace the device soon after implant. The ASR is considered by a number of orthopedic experts to be a defective and suits have been filed on behalf of individuals injured as a result of defective DePuy hip prosthetic implants.

If you or a loved one has had a hip replacement and required additional surgery, suffered infection or experienced failure of the hip implant, it may be due to use of the DePuy ASR System hip device. Your orthopedic surgeon can advise what device was used during your surgery. In addition, the hospital will often give you a card with the information regarding the make and model of the device implanted during your surgery. If the DePuy ASR System was used for your hip replacement and you have suffered the above complications, please contact us now for your free consultation at 1-888-644-3578 or fill our the contact form on this page.

DePuy Hip Replacement Recalls

The DePuy ASR hip replacement device was recalled from the Australian market in December 2009 and from the US market in March 2010 after several hundred complaints from patients who needed costly and painful hip replacement surgeries within a few years of receiving the ASR implant. Individuals receiving the ASR hip prosthesis reportedly have a high failure rate and have an increased occurrence of requiring redo surgery compared with those whose physicians used other hip replacement devices.

DePuy Orthopedics, a division of Johnson & Johnson, announced in the latter part of 2009 its plan to phase out sales of the product worldwide by the end of 2010. By that time however the ASR had been implanted in thousands of people. Approximately 250,000 people in the US alone receive hip replacement implants every year and about one-third of those receive metal-on-metal implants.

In March, 2010 Depuy sent a letter to doctors saying recently analyzed data from Australia indicated a higher-than-expected failure rate than traditional hip replacement on certain types of patients. As well, the data showed that the risk was highest for patients of small stature, which would indicate women and patients with weak bones.

In May 2010 the London Times reported "The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain announced an official review in April of some 40,000 hip replacements." " Doctors are now warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage."

DePuy ASR Defects

A number of orthopedic doctors believe the DePuy metal on metal implant had a design flaw that made it difficult to implant properly, specifically that the component has a narrow window for proper placement. The design of the ASR cup is shallower than some similar devices, and believed to be the implant's problems.

The New York Times reported other problems associated with the DePuy metal on metal implant including the potential for generating large amounts of metal debris during normal wear and tear, which can negatively impact soft tissue and evolve into a health issue for some patients.

The ASR was approved for use by the FDA in 2005. However it was cleared through a regulatory pathway that did not require it to undergo clinical trials.

Some patients who were implanted with the DePuy ASR have developed ALVAL (aseptic lymphocyte dominated vasculitis associated lesion), which is an adverse tissue reaction to metal particles and ions, and pseudotumor (a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris).

More Concern about DePuy Metal-on-Metal Implants

London, UK: Much has been written about DePuy Orthopeadics implants and their potential for early failure due to an implied design flaw. Despite the fact that metal-on-metal hip implants are increasing in popularity and designed to last 15 years or so, early failures have prompted a recall of the DePuy hip replacement system known as the ASR cup. Since then there have been troubling allegations the DePuy metal-on-metal implant could be associated with non-cancerous tumors.

That's the situation overseas in the UK at any rate, according a recent report in the Sunday Times of London. The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain announced an official review in April of some 40,000 hip replacements. Following review, it is expected that many implants will be replaced.

The Sunday Times reports that DePuy is one of the manufacturers involved in the potential replacement of hip implants in the UK.

So far, there has been no mention of potential non-cancerous tumor growth associated with defective hip implants in the US, but the UK reports are troubling—especially given the popularity of metal-on-metal implants and their promise of durability. While most implant procedures are carried out on older patients, the Times reports that eight percent of hip replacements involve people under the age of 55.

Doctors are now warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage.

It has been reported that younger women are particularly vulnerable to the effects of metal debris. Those at risk will have blood tests conducted to determine levels of metal compounds in the blood.

Even though it is phasing out the products subject to the safety concerns, DePuy issued an urgent safety notice back in March emphasizing that its products should not be used in "females of childbearing age" and admitting to "higher than expected" rate of implant removals.

The non-cancerous tumor concern goes back to a report released in January 2008—more than two years ago—when a report to the MHRA found "evidence of genetic damage in patients with certain metal hip implants."

A year ago, the Nuffield Orthopaedic Centre in Oxford published a study showing that women under 40 were at the highest risk of developing such tumors, associated with "soft tissue destruction." In a group of more than 1,200 patients who had hip resurfacing over an eight-year period, four percent required a further operation because of the reaction, described as "pseudotumours." The Nuffield study said 13 percent of women under 40 required a new operation.

Justin Cobb, professor of orthopaedic surgery at Imperial College London, suggested that the problem originated with the alignment of the two halves of the metal-on-metal replacements, adding that such procedures are generally effective. The adverse reaction was identified in only a small number of cases." It's like a Formula One car," he said in statement to the Sunday Times. "If you don't get the wheels perfectly aligned, you will shed them on the first lap."

The patients thought to be affected include those who have undergone full hip replacements involving metal-on-metal implants, or a resurfacing procedure where a metal surface is added to the top of the thigh bone and the hip socket is lined with metal. Following tests, those considered at risk will have their implants replaced.

In 2008, the year of the initial report to the MHRA, there were nearly 65,000 hip replacement operations, of which about 4,500 were full replacements with metal-on-metal implants. About 5,000 patients had metal-on-metal resurfacing operations.

DePuy nonetheless has stood by its product, pronouncing it as safe. "This is not a recall, as data about safety were not the basis for this decision," DePuy said in a statement.

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