Since August of 2010, DePuy Orthopaedics, Inc. issued a worldwide recall of both its ASR XL Acetabular System (total hip replacement) and its DePuy ASR Hip Resurfacing System. In 2003, DePuy released the ASR systems and marketed them as a unique, state of the art implants. What made the ASR systems so unique was the metal-on-metal design, and DePuy marketed these implants as a design breakthrough that would revolutionize the industry, last longer, and provide better movement and flexibility to the patients needing a hip replacement.
However, this ASR design was flawed from the beginning. The cup on the ASR device is too shallow to accommodate the ball that is supposed to fit into the cup. This defect causes the joint’s ball to edge load in the cup and generates metal debris that is released into the patient’s body. This is a phenomenon that is caused both by the shallow acetabulum (the cup) and by the ASR design of metal-on-metal. Indeed, when the metal surfaces rub together in the ASR device, it releases cobalt and chromium ions into the body, which can cause metallosis. Metallosis, in turn, can cause severe complications to the surrounding muscles, bones, and tissue. Indeed, there are many patients that are having spontaneous fractures in the bones surrounding the prosthesis, along with pseudotumors, spontaneous joint dislocation, and a whole host of other painful problems. What is even worse, all these complications make it that much more difficult for the surgeon to replace the defective ASR device and for the patient to have a successful recovery.
DePuy itself is estimating that as many as 93,000 patients received the defective implants. Worse still, DePuy knew about the high failure rate in these devices months before it recalled its products in the United States. In December of 2009, DePuy voluntarily recalled the ASR devices in the Australian market. It was not until August of 2010 that DePuy did the same in the United States. The device was the same – but not the response…for Americans. Accordingly, DePuy will have to answer to the Americans that it has damaged and maimed…in American courts and in front of American juries.