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DePuy Hip Recall Information

If you are one of the thousands of people who had hip replacement surgery using one of DePuy Orthopaedic’s recalled replacement hips then you probably have a number of questions and concerns.

If you have had to have a second surgery in order to replace the defective device, known as the DePuy ASR XL Acetabular system – a total hip replacement system – or the DePuy ASR Hip Resurfacing system – a partial hip replacement system – or have experienced any symptoms such as pain or weakness then you are probably thinking about filing a DePuy hip recall lawsuit.

Only the Acetabular system was made available in the US, however some people may have traveled outside the country to receive the Resurfacing system.

In order to help you out, the experienced medical malpractice attorneys at Ketchmark and McCreight, P.C. have prepared this brief article on the events that led up to the DePuy hip recall and what you might be able to do if you have experienced any of the disastrous side effects of one of the malfunctioning replacement hips.

How did the DePuy hip recall happen?

One of the most controversial aspects of the DePuy hip recall is that there are clear suggestions that the makers of the products, DePuy Orthopaedics, owned by parent company Johnson & Johnson, knew the replacement hips were defective for many years.

The products were given 510(k) clearance from the US Food and Drug Administration (FDA) in 2005, meaning they were approved without having to go through the usual clinical trials. However, by 2008, the FDA had received 400 complaints regarding patients who had one of the ASR devices implanted. In the same year, a report found evidence of genetic damage in patients who had one of the hip implants installed. It was found that 13% of ASR hip replacement patients needed a second surgery to replace the hip.

In 2009, DePuy voluntarily recalled the ASR devices from the Australian market due to data from the Australian Medical Device Registry that showed a higher than expected failure rate of the replacement hip devices.

However, rather than issuing a worldwide DePuy hip recall, the company claimed the Australia recall was due to poor sales. Yet in 2006, DePuy had sent a letter to doctors warning them that the ASR replacement hips had a high failure rate in certain patients, such as those of small stature, including women and people with weak bones.

A total recall of the ARS systems was announced in August 2010. By the time the DePuy hip recall was put into place, 93,000 hip replacement surgeries had been performed worldwide.

What exactly is the issue with the DePuy replacement hips?

The 13% failure rate within the first few years of the DePuy hips being implanted is about double the industry average. Some surgeons have said the ASR device has a design flaw which makes it difficult to implant in patients. While the devices should last about 15 years, one in eight patients has needed a second hip replacement surgery in the first few years of having the hip installed to replace the faulty hip.

Part of the issue with the ASR devices, which may have led to the DePuy hip recall, is that the products are metal on metal implants, a technology which is very new in the making – only about 10 years old. These implants mimic the ball and socket bones found in a natural hip but are made with metal parts, including cobalt and chromium.

What are the symptoms that led to the DePuy hip recall?

Doctors have warned that metal debris from the defective implants can cause a number of serious problems, such as non-cancerous tumors, severe swelling and sinew damage, according to a report in The London Times.

The DePuy hip recall came about because of the devices’ high rate of failure, in which the replacement hips have deteriorated or failed completely. Some of the side effects of a defective hip device include:

  • Hip pain
  • Thigh or groin pain
  • Pain when walking
  • Pain when standing up
  • Pain bearing weight
  • Swelling

When the DePuy hip device deteriorates, it can deposit small pieces of toxic metal into the bloodstream. This can lead to a condition known as aseptic lymphocyte-dominated vasculitis associated lesion, which is the tissue’s reaction to the metal. The tissues might also react by forming pseudotumors. If the ASR hip device fails completely it may become loose, dislocate, or cause the bone around the hip implant to fracture.

Any of these scenarios is likely to cause a lot of pain to the patient, financial hardship and emotional trauma as well as serious risk to that person’s health. If you believe this has happened to you or have received confirmation from a doctor that the device has malfunctioned then you should contact a medical malpractice lawyer about filing a DePuy hip recall lawsuit immediately.

Keep reading more about the DePuy hip recall in this article entitled DePuy Hip Recall Lawsuits.

Categories: Medical Malpractice

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