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ASR Hip Replacement Recall

DePuy Orthopaedics, a unit of Johnson & Johnson, issued a world-wide recall of ASR hip replacement systems on August 26, 2010. The recall includes two products:

  • ASR™ Hip Resurfacing System and
  • ASR™ XL Acetabular System

A large number of ASR hip replacements have been defective or failed completely. Many individuals who received defective ASR hip replacements have had to undergo painful second surgeries to replace the failed ASR hip implants.

The ASR Hip implants can fail by becoming loose, fracturing the bone around the implant, or dislocating the implant's ball and socket. Defective ASR hip replacements can cause swelling, pain, and difficulty walking. Metal particles can flake off of the ASR Hip replacement and enter the bloodstream.

Data shows that DePuy hip system recipients are in need of a second hip replacement procedure at higher-than-expected rates. Replacement procedures are normally only required when an artificial joint causes pain or difficulty in walking. Per DePuy, there are approximately 93,000 of these devices implanted worldwide since they were introduced in July, 2003.

1 in 8 Patients Currently With The Implants Need Revision Surgery

Approximately 400 US patient complaints related to the XL Acetabular System have been submitted to the FDA.  Using the generally accepted standards for this product type, no more than 1 in 20 patients should have a revision within five years. Data shows that five years after implantation, about 12% of patients who had received the ASR™ resurfacing device and 13% of patients who had received the ASR™ total hip replacement needed a second surgery. Revision surgeries are usually technically more difficult, may take longer and the recovery is more prolonged.

DePuy has announced that 12% of patients who received the ASR resurfacing device and 13% of patients who received the ASR total hip replacement need a “revision surgery.”  Revision surgery is a painful and expensive process in which the defective ASR cup is removed, and replaced with a different device.  In short, the patient is required to undergo a second, needless surgery to fix the mistake.

Patients Complain of Pain and Associated Risks

According to a DePuy spokesperson, pain, swelling and problems walking are among patient complaints. Ultimately, these symptoms can lead to more significant complications, including loosening of the implant, fracture of the hip bone and dislocation of the implant.

ASR Hip Replacement Lawsuits

ASR hip replacement lawsuits are already being filed across the country. The law firm of Klein Frank, P.C. is experienced at handling hip replacement litigation. Our attorneys were leaders in the discovery of the corporate responsibility and negotiating the $1.2 billion dollar class action settlement for the defective Sulzer hip replacement.

Important Things to Know Before Having a Defective Implant Removed

Your implant is evidence, do not allow DePuy to take it

Your hip implant is your property. It’s also an important piece of evidence. A representative from DePuy may attempt to obtain your defective hip implant after its removal. Before you undergo hip replacement removal surgery, be sure to notify both the surgeon and the hospital that the removed implant is to be given to you, not to DePuy.

Do not allow DePuy to take photographs during the surgery
A DePuy representative may attempt to be present during the implant removal surgery itself. You should be sure to ask your surgeon if the DePuy representative’s presence is absolutely necessary during the surgery. You also have the right to request that the representative not be allowed to take photographs or videos during the surgery.

DePuy ASR Hip Replacement Lawsuit

If you've been harmed by a defective ASR Hip Replacement, you have the right to file a lawsuit. The FDA had been receiving complaints about ASR hip replacement systems for more than two years before the recall. DePuy continued to sell a defective hip replacement system with a much higher than usual failure rate long after it was warned by surgeons of the device’s problems. ASR hip replacement patients have had to undergo multiple painful surgeries to replace the defective devices, and may face further complications. ASR hip replacement patients who have been harmed by defective ASR hip replacements have the right to file a hip replacement lawsuit and seek compensation for their injuries.

 

Defective DePuy Hip Replacements

This is not the first time DePuy has come under criticism for its ASR Hip replacements. Since the start of 2008, the FDA has received about 400 complaints involving patients in the United States who have received ASR hip replacements.

  • About 13% of ASR hip replacement patients have required a second surgery to replace a failed artificial hip within five years of receiving the ASR Hip Resurfacing System, which is much higher than the industry standard failure rate. 
  • In March of 2010, the company announced that it would be phasing out sales of the ASR hip replacement system by the end of the year. An article in the New York Times quoted orthopedic specialists who said that they believed that the design of the ASR Hip Replacement System was faulty.
  • The ASR hip replacement system had come under scrutiny for its high failure rate, and when the ASR hip replacement recall was announced orthopedic specialists questioned why it had not been recalled sooner.r.
  • DePuy, a subsidiary of Johnson & Johnson, also received a warning letter from the FDA for illegally marketing an unapproved knee device and selling another a hip implant for an unapproved use. This is the eleventh recall that Johnson and Johnson or one of its subsidiaries has issued since September 2009.
 

Experienced Hip Replacement Attorneys

Our attorneys are specialists in medical device litigation, and for more than 25 years, our attorneys have successfully represented our clients and stood up for the rights of people harmed by defective medical devices. We are a nationwide law firm serving clients from all over the country. We handle all ASR hip replacement injury cases on a contingency basis.

To learn more, or for a free consultation with an experienced hip replacement attorney, please email or call us at 303-448-8884.

DePuy has known for years that these products were defective, and discontinued production and sales of the ASR hip replacements in 2009.  

DePuy has announced that 12% of patients who received the ASR resurfacing device and 13% of patients who received the ASR total hip replacement need a “revision surgery.”  Revision surgery is a painful and expensive process in which the defective ASR cup is removed, and replaced with a different device.  In short, the patient is required to undergo a second, needless surgery to fix the mistake.

More about the DePuy ASR Lawsuit
According to published reports, DePuy has stated it will cover “reasonable and customary costs of monitoring and treatment for services.”  DePuy’s product recall notice for the defective implants also states that patient “safety and health is important to DePuy.”  Patients who have received the defective ASR hip implant should be aware of their legal rights before contacting DePuy or Johnson & Johnson.

DePuy has limited its voluntary offer of compensation to the costs of medical care provided. This approach entirely omits the physical pain associated with undergoing an additional, unnecessary surgery, lost wages and decreased earning capacity.  Because patients who were implanted with this defective device are entitled to complete compensation – not just the amount DePuy decides to offer — it is important to consult with a DePuy hip recall attorney before contacting DePuy or Johnson & Johnson.

If you received an ASR hip implant and are experiencing problems, you may qualify for compensation for physical damage, additional surgeries and your pain and suffering. Do not contact DePuy Orthopaedics or Johnson & Johnson without first talking to an attorney with experience handling defective medical device cases nationwide. It's important that you understand your rights.

We handle DePuy ASR hip implant lawsuits in Colorado and nationwide. Contact Klein | Frank, P.C today.