The FDA is blasting DePuy Orthopaedics, a subsidiary of Johnson & Johnson, over the selling of artificial knee and hip replacement implants without FDA approval.
The FDA issued a warning letter to DePuy Orthopaedics in December about the regulatory problems, after inspectors visiting a plant in Warsaw, Indiana discovered implants being manufactured there that were never given FDA approval.
The letter, released by the FDA, has forced DePuy to remove 14 different implant components from the market until the issue can be resolved.
DePuy officials told FDA investigators that the components found at the plant were custom devices made for specific patients, and therefore did not have to get premarket approval. The FDA disagreed, saying that none of the devices qualify as custom devices.
According to the FDA, “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 FDA further stated that “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.”
Not only should the devices not have been sold, but they were manufactured with poor quality control procedures, the FDA warning letter notes. The letter cites the company for using poor design validation procedures, not having a process in place for handling customer complaints and other regulatory violations.
DePuy Orthopaedics was the focus of a major artificial hip system recall in August 2010 when it pulled 93,000 ASR metal hip implants from the market. The ASR hip recall has triggered more than 3,500 lawsuits against the company.
The federal DePuy ASR litigation has been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Ohio as part of an MDL, or multidistrict litigation.
At the time of the recall, Johnson & Johnson indicated that the DePuy ASR failure rate was about 12%. Some expects have suggested that the actual percentage of people who are likely to experience problems with their implant, including loosening, metal poisoning and possible revision surgery, is going to be substantially higher.