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Surgeon and Author, Dr. Stuart Gold,
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What Happened with the Johnson and Johnson Hip Replacement Recall?

February 13th, 2011

In August 2010, Johnson and Johnson issued a recall for hip replacement systems sold by DePuy Orthopaedics, one of its divisions. The two systems involved in this recall were the ASR-XL Acetabular System and the ASR Hip Resurfacing System. Since introducing the devices in 2003, DePuy reportedly sold more than 90,000 of these two systems worldwide.


Johnson & Johnson Hip Replacement Recall

Statistically, it is expected that no more than 5 percent of patients who undergo this type of surgery will need a corrective operation within five years. However, data revealed that between twelve and thirteen percent of patients receiving the ASR systems needed additional surgery within that five-year time span. Surgery to revise a hip replacement is more difficult and the patient’s recovery may take longer than after the initial surgery.

Patients involved in the Johnson and Johnson hip replacement recall typically complained of swelling, pain, and difficulty in walking. If not corrected, these issues can lead to more serious complications. The implant may loosen or dislocate, or the bone may fracture, and falls can result. The devices can also release toxic metals into the patient’s bloodstream.

The Federal Drug Administration granted DePuy permission to forego clinical trials and begin marketing the devices in 2003. In 2008, researchers from the United Kingdom began conducting tests on the prosthesis. They reported that the joint, which placed two pieces of metal in contact with each other, was eroding and leaching metals into the blood.

Early in 2009, DePuy began marketing a new head for their implants, stating that it “reduced associated ion release” significantly when compared to conventional devices that used metal-on-metal construction. There might have been a Johnson and Johnson hip replacement recall at that point, but the company did not act. They did, however, discontinue the ASR devices later in the year, but they never issued a recall or notified the public of potential problems from the implants.

The issue came to a head in 2010, when the UK’s equivalent of the FDA issued alert-advising physicians to monitor patients who had received the devices for cobalt and chromium toxicity. Soon after, the state of Alaska, through its Department of Health and Human Services, recommended that physicians develop a plan to monitor patients for toxicity and the need for additional surgery.

The Johnson and Johnson hip replacement recall announcement stated that the company would cover customary, reasonable costs for treatment, including additional surgery if required. No mention was made of lost wages or compensation for pain or suffering. However, some patients have sued and been awarded settlements.

Until next time,

Stuart

About the Author: Dr. Stuart Gold, M.D. is a board certified orthopedic surgeon who has 23 years experience specializing in sport injuries, joint replacement, arthritis and limb salvage. As the Director of the Orthopedic Institute, Dr. Gold recently published The Patient's Guide To Orthopedic Surgery to help patients better understand the challenges, risks and opportunities of orthopedic care.

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