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Oklahoma ASR Hip Replacement

DePuy Orthopaedics, Inc., a Division of Johnson & Johnson, ASRTM Hip Replacement System Recall

Our ASRTM Hip Replacement System recall attorneys at Richardson Richardson Boudreaux are available to assist you with any questions and concerns about the ASRTM hip replacement system recall.

A division of Johnson & Johnson, DePuy Orthopaedics, Inc., voluntarily recalled the ASRTM XL Acetabular System and ASRTM Hip Resurfacing System after a reprisal from the Food & Drug Administration (FDA) on August 19, 2010. The medical device recall came soon after the FDA warning. The FDA purports that Johnson & Johnson and DePuy Orthopaedics, Inc., never received marketing clearance or approval before releasing the product to the United States medical community. DePuy secured approval for the use of the ASRTM Hip Resurfacing System outside the U.S. only, while the ASRTM XL Acetabular System itself was available globally.

DePuy Orthopaedics, Inc., first issued a notice of the defective product in March 2010 after data from a UK study showed a higher surgical revision rate at 8 to 9 percent after three years when used with smaller heads 50 mm and below. DePuy now has new 2010 data from the National Joint Registry of England and Wales showing the revision rate for the ASRTM Hip Replacement System is actually 12 to 13 percent across the entire size range at five years, with the higher risk being for the smaller heads that generally affect females. The new data prompted DePuy to issue a voluntary recall of all ASRTM products.

Explanation of ASRTM Hip Replacement System Defect

The hip replacement implant is made of metal ball and sockets that wear with time. The friction produces microscopic particles. While this is a normal process, some patients might experience a reaction to the debris particles. Fluid collects in the joint and muscles around the joint. If the condition is untreated, the patient can experience pain and swelling around the joint and soft tissue damage can occur in the muscles, bones and nerves around the hip.

ASRTM XL Acetabular System and ASRTM Hip Resurfacing System Recall Medical Recommendations

DePuy Orthopedics, Inc., has notified medical professionals with instructions on follow-up care for the defective medical device. These instructions include:

• X-rays

If you are experiencing physical symptoms, your treatment provider can evaluate dislocation or separation of the implant from the bone and bone damage with x-rays. If there is a problem with the medical device, surgical revision may be necessary.

• Blood Test

Blood testing is important. Even if you are not experiencing adverse symptoms, a blood test will show the level of microscopic metal particles around your hip. If the level is high, your surgeon may want a repeat blood test in three months.

• Additional Blood Testing or Imaging

If your repeat blood test continues to show a high level of microscopic metal particles, an MRI or ultrasound of the defective product may be necessary. Your surgeon might recommend surgical replacement of the ASR Hip System if these diagnostic tests show a reaction to the microscopic particles.

• General Follow-Up

If you are not experiencing any adverse reaction or if the test results do not indicate a surgical replacement, your surgeon will recommend a course of continued follow-up to ensure that your ASRTM Hip Replacement System continues to function normally.

If additional surgery is necessary, your surgeon will advise you of your options and an appropriate implant system based on your personal health.

Oklahoma Defective Products Law Firm

At Richardson Richardson Boudreaux, our Oklahoma hip replacement attorneys know how frightening a medical device recall can be, especially if you have to undergo additional corrective surgery. Our Oklahoma defective products law firm is the largest plaintiffs’ law firm in Oklahoma and our team of Tulsa defective products lawyers has successfully represented countless clients in product liability litigation.

DePuy Orthopaedics, Inc. and Johnson & Johnson acted irresponsibly by distributing a product without approval from the FDA. If your hip replacement medical device is the ASRTM Hip Replacement System, you may be entitled to damages under the law. Our Tulsa defective product lawyers are on hand to discuss your legal options. Call us today at 918-492-7674 or 877-777-4539 or complete our web form to set up your free consultation.

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