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On August 24, 2010, DePuy Orthopedics, Inc., which is part of Johnson & Johnson, issued a global recall of its ASR hip replacement systems due to a high rate of failure.
The recall comes only days after the FDA sent a warning letter to DePuy for selling other hip and joint products without FDA approval. The recalled products include the ASR XL Acetabular System and the ASR Hip Resurfacing System. DePuy sold an estimated 93,000 of the hip implants systems, which were sold worldwide since 2004 and sold in the United States since 2005.
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DePuy states that about 1 in 8 people with ASR hip components will require "revision" surgery within five years. In other words, patients will require another painful surgery to remove the defective ASR system and replace it with different device. DePuy states:
This recall means additional testing and monitoring may be necessary to ensure your hip implant is functioning well. In some cases patients may need additional surgery.
New data shows that five years after implantation, approximately 12 percent of patients (1 in 8) who had received the ASR resurfacing device and 13 percent of patients (1 in 8) who had received the ASR total hip replacement needed to have a revision surgery.
According to DePuy, the risk for revision surgery is highest with ASR head sizes below 50 mm in diameter and among female patients.
The DePuy ASR devices are metal-on-metal hip replacement systems. Over time, the ball and socket components wear down, generating metal debris fragments. These fragments can cause fluids to build up in the joint and surrounding muscles, and may cause pain and swelling or damage to the muscles, bones and nerves around the hip.
Symptoms of a defective DePuy ASR hip implant may include:
- Hip, leg, groin or lower back pain
- Swelling, inflammation or infection
- Problems walking, standing or sitting
- Fatigue or decline in physical ability
- Audible clicking or crunching sound from the hip area
- Elevated levels of metals in blood
Continuing symptoms may be signs of the implant loosening from the bone, dislocation of the implant, or fracture of the bone.
DePuy recommends that patients with ASR hip implant devices visit their orthopedic surgeon for evaluation and monitoring. If you are uncertain whether you received an ASR hip implant, contact your orthopedic surgeon. You may also contact your primary physician or the hospital where your surgery took place.
DePuy claims that it intends to reimburse patients for "reasonable and customary" out-of-pocket medical costs associated with the recall, after patients have submitted their medical bills to their insurance company or Medicare. DePuy, however, will not compensate patients for their physical and mental pain and suffering of undergoing another surgery and rehabilitation, and ignores any new or aggravated injury or disability, lost wages and other significant expenses caused by its defective hip implants.
If you or a loved one has questions about a potential claim related to the DePuy ASR hip implant recall, please call us today to learn more about your legal rights at toll free 866-292-1582 or submit an online contact form.
We are ready to help you recover the compensation your deserve after suffering an injury due to any type of defective medical device or implant, including (but not limited to):
- Zimmer products, including NexGen and Persona knee replacements
- Stryker devices
- Wright devices and implants
- Biomet products
- Testosterone drugs
- Defective medications such as Xarelto and Eliquis
Dreyer Boyajian LLP has been successfully representing clients in personal injury and products liability cases for over 30 years. We strive to provide our clients with the highest legal and ethical quality of representation. Our goal is simple - Getting you the justice that you deserve. If you have suffered serious injury or financial damage because of a problem with a DePuy ASR hip implant system, it is important that you speak to an attorney to protect your rights.
Contact us today by email or call toll free 866-292-1582 for a free case consultation.