DePuy hip recall: What’s going on?

Hips, knees and other joints wear out as we get older. Artificial hip joints or hip replacements have been around for many years now; some brands and types proving more successful than others. Back in March of 2004, Johnson and Johnson through their subsidiary DePuy introduced the “next big thing” in artificial hip implants: the metal on metal DePuy ASR implant. After selling more than 90,000 of the units, they issued a recall in 2010 with overwhelming evidence that the product was defective. Here’s the rest of the story.
On the American market, the history of the DePuy ASR cup goes back to March 2004 when DePuy started a process known as “510(k)” approval. This type of FDA clearance only requires a medical device company to show that its new medical device is “substantially similar” to other devices already on the market. DePuy claimed its new ASR acetabular cup was “similar” to its prior cup, the DePuy Pinnacle device.
One crucial distinction between the Pinnacle and the ASR, however, was external fixation. While the Pinnacle was designed to be fastened to the bone with screws, the ASR offered surgeons no means to fasten it to the patient’s bone. Its only means of fixation was for bone to grow into the device.
Based on the representation that the ASR was the same as a different device, DePuy began marketing and selling the ASR. DePuy and Johnson & Johnson were never required to go through extensive clinical trials or to otherwise prove that the ASR was free of dangerous defects. Almost immediately, the ASR began to fail at alarming rates. Metal byproduct seeped into patient’s bloodstreams and inflamed surrounding tissues. Revisions and removal became commonplace. Now, evidence has surfaced that the company knew of these defects long before the recall in mid 2010, yet chose to keep the information from patients and doctors.
Patients who have DePuy ASR implants may face other serious health issues in addition to revision surgeries and the pain associated with such procedures. Metallosis has now been linked to DePuy implants. Metallosis occurs when the metal-on-metal movement of the hip implant causes friction and releases potentially dangerous levels of chromium and cobalt ions into the body. This condition can result in nerve damage and rashes. It can also require the need for corrective surgery.
As can be imagined, many injured and affected patients are pursuing legal action. Many lawyers and firms are advertising for these cases. As with any personal injury case caused by a defective product, damages can include medical bills, wage loss, future cost of care and healthcare, and past and future pain, suffering and other noneconomic damages.

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