Although DePuy’s ASR hip implant device was recalled in August, 2010, the company has continued to sell its Pinnacle model, even though the DePuy Pinnacle hip implant and the ASR have many design features in common. The Pinnacle has been in production since FDA approval in 2000, with over 150,000 of the devices sold and implanted between that time and today—despite the fact that while the Pinnacle was designed to last at least 15 years, orthopedic surgeons are reporting failures within 1-2 years. While the DePuy Pinnacle and the ASR are similar, there are also specific differences between the two, including:
· The Pinnacle has an outer shell, while the ASR cup is a solid piece of metal
· The Pinnacle allows surgeons the option to place a metal, ceramic or polyethylene liner inside the metal outer cup
The goal—according to DePuy—of offering the variety of liners was to allow surgeons more freedom in choosing a bearing surface for the individual patient, based on body type, age, and level of activity. It appears that the primary issue with the DePuy Pinnacle hip implant is associated with use of the Ultamet metal liner. When the metal liner is used, the result is friction and corrosion between the cup and ball-shaped head. This friction leads to the generation of excess metal ion debris; these microscopic cobalt and chromium ions can enter the bloodstream or the surrounding hip tissue. When the ions burrow into the hip tissues, inflammation, pain and loss of mobility can result, as well as destruction of the bone and tissue. The implant can fail completely, requiring hip revision surgery. Metal ions which enter the bloodstream can lead to chromium and cobalt poisoning, with such adverse health symptoms as:
· Gastrointestinal disorders
· Skin rashes
· Vertigo
· Depression, anxiety, irritability
· Cardiovascular issues
· Loss of hearing and vision
· The development of certain types of cancers
· Pseudo-tumor development
· Disruption of DNA
· Renal failure
· Hypothyroidism
· Neurological disorders
· Short-term memory loss
Despite the more than 1,300 adverse event reports submitted to the FDA regarding the DePuy Pinnacle hip implant—and specifically the Ultamet metal-on-metal Pinnacle liner—as well as the more than 4,000 federal and state lawsuits currently filed against DePuy and Johnson & Johnson, the companies continue to maintain the Pinnacle implant is safe, with no design defects. Lawsuits against DePuy and Johnson & Johnson dispute this claim, alleging defects were deliberately concealed and misrepresentations were made to consumers regarding the safety and effectiveness of the Pinnacle, when used with the Ultamet metal liner.
Design Flaw Theories of the DePuy Pinnacle Hip Implant
One of the theories regarding the design issues associated with the Ultamet metal-on-metal Pinnacle liner is that the device has one of the lowest clearance levels in the industry—the only other implant with a clearance level this low is the recalled DePuy ASR. Experts believe there is a very narrow margin for proper placement of the Pinnacle hip implant with the Ultamet liner. Many of the complaints received from the FDA regarding the DePuy Pinnacle hip implant center around the Pinnacle’s propensity to prematurely separate from the bone, in addition to the DePuy Pinnacle metallosis and Pinnacle chromium and cobalt poisoning.
Although there has been no recall of the DePuy Pinnacle hip implant, if you feel you have been harmed by the Pinnacle—particularly when coupled with the Ultamet metal-on-metal Pinnacle liner—you should see your physician and have blood tests done to measure your levels of cobalt and chromium. After seeing to your health, it could be in your best interests to speak to a DePuy Pinnacle hip lawyer regarding a potential DePuy Pinnacle lawsuit.