Articles Posted in Defects

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Femur Fracture Increase RateThe medical device manufacturer Stryker announced a voluntary recall of both the ABG II and Rejuvenate hip implants due to potential risks involved with the device’s modular neck stems. The company says that the device’s stems are at risk of corrosion or fretting, which could manifest as adverse tissue reaction involving intense swelling and/or pain.

Today, thousands of patients have had the device implanted and are now requiring treatment to reduce debilitating symptoms. Some patients have experienced a significant reaction to the device and need revision surgery for a secondary hip replacement. Unfortunately, developing a femur fracture in surgery can happen accidentally during the removal of the existing device, or is the only alternative if the surgeon needs to break the bone to unlock it from its position.

A Rush to Market A Medical Device Without Extensive Testing

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Stryker Hip Replacements and CorrosionSome of the most popular terms often heard in discussing the Stryker hip recall include “corrosion,” “metal ions” and “metallosis.” As you learn more about the Stryker lawsuits, you may read FDA articles and research studies that frequently use these terms. If you have a Stryker hip implant, you should take care to understand these terms. Those who have Stryker hip implants may be at risk for developing metallosis, which is a type of metal poisoning caused by the release of metal ions into the bloodstream. They may also suffer from corrosion of the Stryker Rejuvenate or ABG II systems, which refers to the wear and tear of the hip implant. Corrosion can cause a person to suffer from extreme pain, swelling, bruising, redness, itching and other uncomfortable conditions.

The U.S. Food and Drug Administration (FDA) has even started reporting on the negative corrosive effects of Stryker hip implants and other metal-on-metal hip devices. After initially approving the Stryker hip systems on June 3, 2008, without extensive clinical safety testing, it seems that the FDA has now reversed its initial decision to approve the product. The FDA later issued warnings about the potential defects in the Stryker hip implants, and these warnings ultimately spurred Stryker Orthopaedics to initiate its own voluntary recall of the Rejuvenate and ABG II systems in April of 2012.

Why Is Metal Corrosion Relevant to the Stryker Hip Implant Recall?

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Failure is High with Hip ReplacementsThe Journal of Bone & Joint Surgery has been leading the way in publishing detailed research that reveals the alarmingly high rates of Stryker hip implant failures. The Journal has published a total of four research studies tracking adverse local tissue reaction and corrosion caused by Stryker hip implants from May 2013 to March 2014. What is most troubling about these research studies is that they feature expert researchers who were once former paid Stryker consultants. Individuals who were once paid to create Stryker hip implants are now speaking out against the dangers and risks associated with the hip implants.

The most recent research study, “Early Corrosion-Related Failure of the Rejuvenate Modular total Hip Replacement,” has discovered that pain and high Co serum levels in hip implant patients were strong predictors of the need for a revision surgery. Leading the research panel was Dr. Stephen J. Incavo, MD, an individual who once implanted over 100 Stryker Rejuvenate hips. Dr. Incavo also served as a paid Stryker consultant during the time in which he implanted these hips. Ultimately, the research study concluded that the high rate of corrosion-related revision with Stryker Rejuvenate neck stems was “striking.” In other words, the Stryker Rejuvenate hip implants have a tendency to corrode and release metal ions into the bloodstream.

Surmounting Literature Reveals Stryker Rejuvenate Failures

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How Cobalt reacts to the bodyCobalt Poisoning From A Stryker Hip Device

The chemical element cobalt is found in plants, water, rocks and soil, making it naturally absorb in the body through the food and beverages we drink. The cobalt found in what we ingest are in such minuscule trace amounts that they are not toxic in our systems. However, when larger amounts are introduced to our bodies, cobalt can become poisonous and cause extreme harm to our organs as well as death. For those with malfunctioning metal hip implants that contain cobalt, this has become a very real and dangerous risk to their health.

Effects Of Cobalt In The Body

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How the body reacts to ChromiumChromium Poisoning From Stryker Hip Implants

Chromium, a chemical element, known by its symbol Cr and as 24 on the atomic chart, is a gray metal that is found in many sources, including food, water and minerals. Mostly used in creating metals such as stainless less and chrome plating, it is highly prized for its ability to resist corrosion.

Although commonly found in trace amounts in consumable products, this metal can be extremely toxic to the human body when larger amounts are introduced to the body, causing serious and even deadly illnesses. It is important to understand the symptoms associated with chromium toxicity and to know how you may be exposed to this deadly metal through hip implants.

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TV show helps with diagnosisMany people enjoyed watching Dr. House solve mysterious ailments over the eight seasons it ran on the Fox network. Although fictional, many of the medical cases that were portrayed in the show were based on real illnesses that plague the human body. In a strange turn of events, real-life doctors in Germany credit the show with helping them save the life of one of their patients.

Dr. House To The Rescue

When a 55-year old man in Germany was referred to their clinic from his regular physicians, doctors at Philipps University of Marburg’s clinic were stumped by his symptoms. The man was diagnosed with heart failure, with his heart only pumping blood at a fraction of the normal rate. In addition, the man had suddenly begun to lose his eyesight and hearing, had a fever and many other seemingly unrelated problems. It was a perfect case for Dr. House.

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Elevated Cobalt levels are Causes for ConcernElevated Cobalt Levels In Stryker Rejuvenate Patients

There are an increasing number of patients who underwent hip-replacement surgery and are finding out that they have “elevated” cobalt levels in their blood. One of the problems is that while we know that elevated cobalt blood levels are not healthy, there is not a great deal of information available about the long-term effects.

Orthopedic surgeons and metal toxicity expert are yet to agree upon ‘standard’ cobalt levels. They also do not agree when patients reach dangerous levels. However, they do agree that blood levels over 5 micrograms of cobalt must be regarded as abnormal when observing previous occupational studies on cobalt exposure through skin contact, ingestion, or inhalation. Because the metal wear debris is actually inside of the patient with these metal-on-metal hip implants, it has immediate access to the bloodstream and bodily tissue. This means that it is potentially even more dangerous than someone being exposed to an external cobalt source.

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Metal Poisoning is a Health ConcernAfter a study of 17,000 patients found that four out of every ten patients was suffering from malfunctions from hip replacements, metal on metal hip replacements have been banned. National Health Services have declared an official ban of the dangerous hip replacements and NHS facilities will not perform any such procedures involving metal hip implants.

This news does not come as a surprise to doctors and patients alike. There has been a history of complaints stemming from patients who have used hip replacements. Two models have already been deemed unsuitable and have been taken off the market. Those who have already had a hip implant inserted must have annual check-ups and regular blood tests to ensure that there is no sign of metal poisoning or infection.

The issue has been raised due to numerous complaints from patients of metal poisoning from hip replacements. Many patients have had to undergo second surgeries to fix the damage that has been caused by the implants. Surgeons have commented that these artificial joints do not seem to be doing the job adequately and are failing to provide comfort and relief to the patients.  With these metal on metal hip replacements malfunctioning in the body, there is a severe risk of toxic materials being leaked into the body.

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