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J&J unit recalls 93,000 hip implant systems

By Parija Kavilanz, senior writer

NEW YORK (CNNMoney.com) -- Johnson and Johnson unit DePuy Orthopaedics, already in hot water with government regulators, issued a global recall Thursday of two hip aid systems after finding that more people than expected suffered pain which required additional surgery.

DePuy, which has sold about 93,000 units of its ASR XL Acetabular System and the ASR Hip Resurfacing System, said recent data received by the company showed an increase in the number of people who have had a second hip replacement surgery, also called a "revision surgery."

Both products were discontinued late last year, the company said.

The company said the information showed that five years after implantation, approximately 12% of patients, or 1 in 8, who had received the ASR resurfacing device, and 13% of patients, or 1 in 8, who had received the ASR total hip replacement needed a second surgery.

Pain, swelling, problems walking are among the systems that patients complained about, the company said.

If those symptoms continue, it could lead to more significant complications, including loosening of the implant, fracture of the hip bone and dislocation of the implant, the company said.

DePuy said it will cover "reasonable and customary costs of monitoring and treatment for services," including additional surgery costs associated with the recall of ASR systems.

Already in hot water

Thursday's recall marks the second problem for the Johnson & Johnson unit in a week.

On Tuesday, the Food and Drug Administration (FDA) issued a warning letter to DePuy for selling hip and other joint products without the agency's approval.

The FDA said the medical devices maker has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act.

The agency warned the company to immediately stop sales of the products until it comes into compliance with the agency's requirements.

Meanwhile, parent company Johnson & Johnson (JNJ, Fortune 500) itself has come under intense FDA scrutiny in the past year. Its drugmaking unit McNeil Consumer Healthcare, which makes well-known cold and pain drugs such as Tylenol and Benadryl, has received negative inspection reports and warning letters tied to manufacturing lapses at its U.S. factories.

In May, McNeil shut a plant in Fort Washington, Penn., after the company recalled millions of children's Tylenol and other over the counter drugs.

Regarding Thursday's recall, DePuy is advising patients who have received these hip systems to contact their surgeon for additional tests, including blood testing or imaging to evaluate how the implant is functioning.

The company said consumers can also contact its helpline at 888-627-2677 from 8 a.m. to 9 p.m. EST, Monday through Saturday.  To top of page

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