FDA Warns DePuy Orthopaedics On Unapproved Device Component

The U.S. Food and Drug Administration (FDA) just issued a warning to Johnson & Johnson’s DePuy Orthopaedics for marketing a number of unapproved medical device components.

The drug and device giant’s subsidiary sold more than a dozen different orthopedic devices without ever having received required regulatory approval, said the FDA in a just-released warning letter, wrote the Asbury Park Press. The letter also said that DePuy had a quality system in place that was not in compliance with FDA mandates.

The letter, from Steven D. Silverman, FDA’s director of the office of compliance, was sent December 8, 2011 and followed an inspection that took place May 10, 2011 – June 7, 2011 said the Asbury Park Press. In his letter, Silverman said that DePuy manufactured 14 devices, including knee and hip systems, that never received pre-market clearance or approval from the agency.

DePuy said it believes that the devices in question were custom-made, surgeon requested devices meant for use in individual patients and to match specific anatomical needs, which would make them exempt from the FDA’s approval process, noted the Asbury Park Press. Regardless, said the FDA, the devices did not meet agency criteria, partly because once the devices were completed, they could have been made available to other physicians.

“The fact that the 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,” Silverman wrote, The Asbury Park Press, reported. DePuy spokeswoman, Lorie Gawreluk, argued that, since 1976, custom medical devices have been exempt from the FDA’s pre-market review requirement and that it believes it is in compliance with FDA mandates. However, said Gawreluk, “The company has made the decision at this time not to provide custom devices,” The Asbury Park Press wrote.

The FDA also cited the device maker for its failure to comply with quality regulations, including that it did not have sufficient procedures in place to ensure devices met users’ needs, that it did not have appropriate procedures in place for complaint review, and it did not ensure the employee handling nonconformance issues was notified when a product was not in conformance, said the FDA, according to The Asbury Park Press. Gawreluk replied that, “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.”

As anyone who reads this blog knows, DePuy has been the focus of a number of recalls, patient injury issues, and FDA reviews. For instance, last May, the FDA directed 21 makers of all-metal hip implants, including DePuy Orthopaedics, to conduct post-market studies of their devices to determine if they were shedding dangerous amounts of metallic debris in patients. The FDA’s order followed the August 2010 worldwide recall of DePuy’s ASR hip implant after it was found that it failed prematurely in an unusually high number of patients. The ASR, as well as an all-metal version of DePuy’s Pinnacle hip implant, has been named in lawsuits by U.S. patients and, this November, a study of hip implants commissioned by the FDA found that new versions, including all-metal designs, offered no benefits over older types of implants. It also found that people who received all-metal hip implants likelier need repeat surgery than those who received traditional implants.

Hip implants introduced to the U.S. are often brought to market fairly quickly. The FDA allows manufacturers to gain approval for hip replacements through its 510(k) clearance protocols when a device can be shown to be “substantially” equivalent to products already on the market. Such approvals don’t require human clinical trials.