Warning Letter Spurs DePuy to Halt Custom Device Sales

The arrows continue to fly in the direction of Johnson & Johnson’s DePuy Orthopaedics division. And, yet again, the U.S. Food and Drug Administration (FDA) is holding the bow. The FDA issued a warning letter to DePuy for allegedly marketing products that had not properly been cleared by the agency.

The FDA’s Center for Devices and Radiological Health (CDRH) sent a warning letter dated Dec. 8, 2011, outlining devices or device components it claims lack proper premarket approval (PMA) clearance or which were modified in such a way that they require a new 510(k) application.

The agency said DePuy also failed to notify regulators that it planned to distribute 14 products as custom devices. The company marketed them as custom because they were designed to conform with different patients’ anatomies. The agency disagreed.

“These devices do not deviate from generally available devices or from applicable performance standards, and they have common, standardized design characteristics, chemical and material compositions, or manufacturing processes,” wrote Steven D. Silverman, director of the Office of Compliance at CDRH. “Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured. The fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”

The agency urged the Warsaw, Ind.-based device maker to “take prompt action” to address the issues, or face possible fines, seizure and injunction.

The letter was based on information gathered during FDA inspections that took place from May 10 to June 7 last year and also noted several quality issues, including inadequate complaint review procedures and inadequate procedures to ensure devices conform to a user’s needs, according to the letter.

Among the products cited in the warning letter were the PFC Sigma Knee System, the Agility Total Ankle Prosthesis, Global humeral stems and TriFlange Acetabular Cups as well as additional total hip components.

The company is halting sales of all custom devices—not just the products cited in the FDA letter—for the foreseeable future.

“While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices,” according to a statement released on Jan. 18.

The FDA also claimed DePuy had failed to establish adequate design procedures to ensure the devices conformed to their intended use. In addition, the agency said the company lacked a proper statistical method for detecting recurring quality problems.

“DePuy has implemented a number of actions to address concerns raised in the inspection, and has responded to all concerns raised in the warning letter,” the company statement continued.

Custom devices and instruments have caused FDA regulators to scratch their heads recently. ConforMIS was the first company to receive 510(k) clearance to market its iTotal CR Knee Replacement System in early 2011, following a lengthy review period. In 2010, Biomet received an FDA warning letter regarding its Signature customized cutting guides for total knee replacement, and the company temporarily suspended marketing of the device until it was cleared by the agency in February of 2011. Stryker received 510(k) clearance in May last year for the Shapematch, which it acquired when it purchased OtisMed.