Johnson & Johnson subsidiary DePuy Orthopaedics is recalling all of its ASR hip resurfacing and ASR XL acetabular hip replacement systems worldwide due to elevated rates of revision surgeries to replace the devices, the company said Aug. 26.

While "very few" of the devices remain on the market, following the firm's decision in 2009 to discontinue the ASR system due to declining demand and efforts to refocus on development of next-generation systems, about 93,000 patients have the implants worldwide, according to the company.

DePuy is advising patients with the implants to visit their surgeons for "evaluation of their implant performance," and says that "yearly monitoring is recommended ... even in the absence of symptoms."

The firm has pledged to cover "reasonable and customary costs" of monitoring and treatments, including revision surgeries if they are needed.

While the company says it is too soon to predict how much the effort could cost, Wells Fargo analyst Larry Biegelsen estimates the costs to J&J at a "manageable" $1.2 billion over five years, including patient settlements to cover pain and suffering.

Data Show Five-year Revision Rate Of 12%-13%

While "the majority of ASR hip replacement surgeries have been successful," according to the company, not-yet-published data from the National Joint Registry of England and Wales shows a five-year revision rate of 12% for the ASR hip resurfacing system and 13% for the ASR XL acetabular hip replacement system.

The revision rates cut across all size ranges, but the risk of revision was highest with ASR hips with head sizes smaller than 50 mm in diameter, and among female patients, DePuy noted.

In contrast, the 2009 Australian joint registry showed ASR revision rates of 6% at three years, explained Lorie Gawreluk, VP of worldwide communications at DePuy.

"Previous post-market surveillance data ... had shown lower revision rates and that the ASR hip was performing in line with other devices in its class," the firm pointed out in an Aug. 26 statement.

Gawreluk noted that separate, unpublished data earlier this year showed a slightly higher revision rate of 8% to 9% for smaller head sizes of the ASR systems, at which point DePuy alerted surgeons to the problem (¹ Also see "Regulatory News In Brief" - Medtech Insight, 15 March, 2010.).

The U.K.'s Medicines and Healthcare products Regulatory Agency issued a medical device alert for the ASR systems in May in response to the higher revision rates (² Also see "International News In Brief" - Medtech Insight, 7 June, 2010.).

After the most recent data emerged with revision rates nearly double those of the 2009 Australian data, "we decided it was in the best interest of patients to do the recall," Gawreluk said.

She noted that many factors determine the success of a joint replacement, including device placement and patient anatomy, and the firm does not know exactly what caused the ASR problems.

DePuy has notified FDA and other global regulatory agencies of its "voluntary" recall. The firm notes that while the ASR hip resurfacing system is only available outside the U.S., the ASR XL system is available worldwide. The devices debuted in 2003 and 2004, respectively.

Testing, Not Automatic Revision, Is Advised

Expanding on the scale of the action and the potential impact to patients, Gawreluk cautioned that "the direction is not to automatically bring in all your patients and revise," but rather "to do the testing."

"Physicians should only remove the device if there are symptoms or if the testing shows problems with the implant," she explained.

DePuy says it is "constantly" surveying all available post-market data for its devices. "We get unpublished data, we get published data, we see certain centers, we see the joint registries, we get clinical trial data," Gawreluk said. "With any product, we always are looking at the data."

Congress, meanwhile, has been paying closer attention to orthopedic implant manufacturers' processes for monitoring and responding to post-market experience with their devices (³ 'The Gray Sheet' Aug. 9, 2010).

- Jessica Bylander ( ⁴ j.bylander@elsevier.com )

J&J/DePuy Recalls ASR Hip Systems - Effort Could Cost $1.2 Bil.

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