In 2009, following a Food and Drug Administration (FDA) letter which voiced concerns about the safety and poor performance of a DePuy hip implant, DePuy Orthopedics began phasing out use of the implant. According to recently uncovered internal documents, executives at the company did not pull the product (an articular surface replacement or ASR) off the shelf. Instead, they opted to continue to sell the existing stock of potentially defective medical devices.
At the time of the 2009 letter, the DePuy hip replacement was used in other parts of the world. However, due to concerns about its safety, the FDA confidentially notified the manufacturer that it did not meet approval for sale in the United States. Though this version of the DePuy hip implant, whose design was for a hip replacement procedure known as resurfacing, was denied, a similar implant was already in use.
The model marketed in the U.S. as the DePuy Pinnacle hip implant was substantially similar to the non-approved version. The implant contains a metal cup that replaces the patient's hip. Many experts believe that the metal cup, which is part of the design of both versions of the product, is the source of the implant's failure.
Continued Marketing to Sell Remaining Stock
DePuy executives indicated that the hip implants performed well and there was no need to cease sale of the product. Instead they pointed to slow sales as the reason to phase out continuing sales of the implant. DePuy chose to sell their remaining stock until it was "depleted," as stated in an internal email from a company employee. Other company emails illustrate knowledge of the problems during the testing phase of early versions of the hip implants.
In 2010, the questionable devices were recalled. Yet during the eight years prior to the recall approximately 30,000 DePuy implants were used in the United States. Some of the implants were used for New York area patients.
The implant is at this time known to have high rate of premature failure. Severe pain can result from metal debris that fragments off the devices as the metal wears down. For these patients a second hip replacement surgery is generally required.
If you experience complications following a hip replacement surgery that used a DePuy ASR device, an experienced defective medical device attorney can make sure that your rights are protected.