In the previous post, we looked at the difference between ASR surgery and total hip replacement surgeries. We also discussed the Depuy’s “metal-on-metal” (MoM) design. Now, let’s look more deeply into the failure of the metal-on-metal design.
The design problem with the Depuy ASR Cup.
The defect in the Depuy ASR artificial hip appears to be related to design. Orthopedic experts have stated that the design of the ASR cup, which is shallower than standard cups made by other companies, is one aspect of the Depuy ASR Hip’s problems. Dr. Thomas Schmalzreid, a surgeon who designed the Depuy ASR Hip has stated that Depuy had known since 2008 that the Depuy ASR cup may have design flaws. Dr. Schmalzried has said that Depuy officials realized in the first few years that the Depuy ASR cup might be more of a challenge to implant properly then competing cups. Dr. Schmalzried has stated that “the window for component position that is consistent for good, long-term clinical function is smaller for the [Depuy ASR Hip]” than other cups. That is a highly technical (and bone dry) way of explaining that the ASR cup is harder to implant properly into the hip cavity for long-term successful hip surgeries.
Despite its apparent knowledge that the Depuy ASR Hip had a defect and that it had failed hundreds of times, causing hundreds of patients to undergo painful revision surgery, Depuy continued selling the defective hip into 2010. Depuy thus appeared to conceal the known defects from doctors and patients and misrepresented that the Depuy ASR Hip was a safe and effective medical product.
Over five billion in sales in 2009 alone.
Depuy sold more than $5.4 billion in ASR hips in 2009 alone. Hip implant sales were vitally important to Depuy’s parent company, Johnson & Johnson, and Depuy has been one of Johnson & Johnson’s most profitable businesses.
In 2010, Depuy began to disclose some of the more alarming problems with the Depuy ASR Hip. Depuy sent a letter to doctors warning them of the failure rate associated with the Depuy ASR Hip. Depuy admitted that the Depuy ASR Hip suffered from a “higher than expected revision rate,” and that data showed that 5.4% of the Depuy ASR Hips implanted had been surgically replaced after only three years. The letter also stated that Depuy was planning to stop selling the Depuy ASR Hip because of “declining demand.” Which, with all the evidence of product failures, now seems ridiculous.
On August 25, 2010, Depuy confirmed that in the first five years after implantation, approximately 13% of patients (1 in 8) who had received the ASR total hip replacement needed to have a revision surgery. Obviously, this is a terrible result.
At that time, Depuy also confirmed that at least 93,000 people have had Depuy ASR hips implanted in their bodies, meaning that at least 11,700 people could eventually suffer a hip failure and be forced to undergo a painful surgery to remove and replace it.
The August 2010 Depuy ASR Hip Recall
On August 26, 2010, Depuy issued a worldwide recall of its ASR XL Acetabular Hip Replacement System and Depuy ASR Hip Resurfacing System and all components for these devices based on the higher percentage of patients who needed to undergo risky and painful revision surgery.
In the years since the recall, thousands of innocent people have been hurt, some badly by the failed ASR hip. If you underwent a hip replacement surgery in the last ten years, and have had discomfort or other unusual complications, you should arrange a visit with your surgeon and check to see if a Depuy ASR Hip was implanted in your hip.
More than 12,000 people have now filed lawsuits following injuries after implantation of the Depuy ASR Hip. As more patients suffer failures from hip replacement surgeries, this number will rise.
In our next blog post, we identify the first four things you should do if you believe you have a defective artificial hip.
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