DePuy Hit with Warning Letter, Hip Implant Recall

It’s been a rough week for Johnson & Johnson.

Within days of receiving a warning letter from the U.S. Food and Drug Administration (FDA), the company’s orthopedics division announced recalls of two hip replacement devices. Johnson & Johnson added to the regulatory woes onAug. 23 with its ninth product recall of the year, this one for millions of 1 Day Acuvue contact lenses sold in Japan and two dozen other countries in Asia and Europe.

On Aug. 26, Johnson & Johnson’s DePuy Orthopaedics unit announced the recall of its ASR XL Acetabular System, a hip socket used in traditional replacement surgery, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur in order to preserve more bone. The company said it is recalling both products due to the number of patients who needed a second hip replacement.

“We regret that this recall will be concerning for patients, their family members and surgeons,” DePuy Orthopaedics President Dan Floyd said in a prepared statement. “We are committed to assisting patients and healthcare providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.”

About 93,000 ASR devices have been implanted in patients worldwide, according to DePuy. And while the recall may have come as a surprise to some patients, experts claim it was inevitable, saying failure rates and patient complaints doomed the device. Over the last two years, the FDA has received about 400 complaints from American patients who received the implants, according to a March article in The New York Times.

Around the same time the Times article was published, the British agency that regulates medical devices issued an advisory on metal debris generated by hip implants. Devices such as the ASR products have come under fire in recent years because the metal-on-metal bearings can generate debris from wear, which can cause inflammation and tissue damage in certain patients.

Late last year, DePuy said it was phasing out the implants because of slowing sales. In March, the company warned doctors that the implants might have a high failure rate in some patients. In a letter dated March 6, DePuy told doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patients. The letter said the data shows that the risk is highest for patients of small stature, a group that typically includes women, and patients with weak bones.

Many hospitals that specialize in joint replacement surgery had already noticed a higher failure rate with the DePuy hip implants, Joshua J. Jacobs, M.D., chairman of orthopedic surgery at Rush University Medical Center in Chicago, told the Times. “Most major medical centers have seen issues with this device. This does not come as a surprise,” he said.

Maybe not, but the FDA’s claim on Aug. 24 that DePuy is selling hip and other joint products without the agency’s approval certainly was unexpected. The FDA accused DePuy of 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.

“A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale,” the FDA said in a warning letter to the company. In addition, the product has been misbranded, the letter stated.

The FDA warned DePuy to immediately stop selling the products until it complies with the agency’s requirements. A spokeswoman for DePuy said the company is investigating the FDA’s claims.