Australian Agency Issues Warning For Stryker LFIT Anatomic CoCr V40 Femoral Heads
If the name Stryker Orthopedics sounds familiar, it should. Not only is Stryker Orthopedics one of the world's largest manufacturers of knee and hip replacement devices, but problems associated with some of those products have led to high-profile medical device recalls and entangled the company in litigation.
In late September 2016, the Australian Government Department of Health's Therapeutic Goods Administration— the Aussie equivalent of the Food and Drug Administration (FDA)—issued a hazard warning for Stryker's LFIT V40 femoral heads, citing a higher than usual rate of failure. While the FDA has yet to comment on this particular Stryker hip replacement component, the Australian warning has led many to speculate that a U.S. recall is imminent.
What's Wrong With the LFIT V40?
Utilized in many of Stryker's hip replacement devices, LFIT V40 femoral head components are made of a cobalt and chromium alloy that's subject to metallic corrosion. In Stryker LFIT V40 femoral head components made before 2011, the corrosion eventually weakens the head, as well as the neck of the stem that connects the head to the femur, which can lead to catastrophic dissociation, where the femoral head snaps right off. The metal-on-metal design also allows for grinding and fretting, releasing metal fragments into bones and tissues, which may cause a form of metal poisoning known as metallosis.
Metal-on-Metal Design Issues
This isn't the first time Stryker Orthopedics had problems using metal-on-metal designs in its hip replacement products. In 2012, the company recalled two popular products— the Stryker Rejuvenate and Stryker ABGII modular hip stem devices—due to similar problems with corrosion, fretting, and premature failure.
Problems and Complications Associated With Faulty Stryker Devices
Flaws in Stryker's hip replacement device designs are associated with a variety of painful side effects and complications. The metal shavings released when the metal-on-metal components grind together may result in metallosis, which can cause symptoms such as:
- Severe pain
- Swelling and inflammation
- Bone deterioration
- Metal toxicity
- Aseptic fibrosis and local necrosis
- Loosening of the hip implant
- Hip replacement failure
- Gastrointestinal issues
- Recurring infections
- Feelings of burning, tingling or numbness in the extremities
As bad as metallosis can be, it's not even the worst complication associated with a Stryker hip implant device that fails to perform as expected. For example, patients who experience catastrophic dissociation will need invasive and painful reconstructive procedures to correct the problem.
Stryker's hip replacement systems use fixed stems that encourage the bone to grow into the stem's surface, making it a permanent part of the femur. These stems must be broken away from the bone during reconstruction and, in severe cases, doctors may even have to cut the femur in half in order to remove the faulty stem. After the old stem is removed, the femur is wired back together in preparation for the installation of the new stem.
Patients with Stryker LFIT V40 femoral heads may require multiple revision procedures and can even suffer new dislocations after revision surgeries. Additionally, multiple surgeries can put patients at risk of being exposed to hospital-related infections.
Do You Need an Attorney?
If you've experienced adverse effects caused by faulty Stryker LFIT V40 femoral heads, don't wait until the company or the FDA issues a recall to explore your legal options. A knowledgeable, experienced personal injury attorney can help you pursue compensation for your injuries, including pain and suffering related to multiple hip replacement revision procedures.
Michael McGartland is a skilled attorney who is board certified in Civil Trial Law by the Texas Board of Legal Specialization. He has more than 30 years of experience handling negligence-related injury and product liability cases. McGartland is committed to working aggressively and tirelessly to obtain the best possible outcome for his clients. To schedule a free initial consultation to discuss the details of your case, complete McGartland Law Firm's online contact form today.