Defective Hip Replacements
Each day, hundreds of patients undergo surgery to have their natural hips replaced with artificial devices. Whether it’s due to a traumatic injury or aging, natural hips sometimes wear out. Metal artificial hips were supposed to be a good substitute. Instead, a growing number of these same patients have found that metal artificial hips may cause more injuries than first thought. Many of these same patients are undergoing revision surgery much sooner than they anticipated.
Today, the U.S. Food and Drug Administration (FDA) has warned patients to be cautious about their metal hip devices. A growing body of evidence shows that these devices can fail at a higher rate than their plastic or ceramic counterparts and cause longer-lasting injuries. With more than 500,000 people in the United States alone who have received metal hips, some medical professionals have called the problems a public-health crisis.
In the past five years alone, several major artificial hip manufacturers have recalled their devices. That includes some of the biggest names in orthopedic manufacturing:
Stryker Rejuvenate and Stryker ABG II
Approved in 2008 and 2009 respectively, both devices were meant to help surgeons and patients by allowing greater flexibility. The Rejuvenate has six stems and 15 necks and was made for younger patients because of longer-lasting bodies and a greater range of motion. The ABG II has eight right and eight left stems and 10 modular necks for greater stability. Both are made from the company’s proprietary titanium alloy. Shortly after surgeons began implanting the devices, researchers found that they were linked to increased corrosion and fretting. By 2012, both devices were recalled. The company urged patients to undergo consistent tests to ensure against heavy metal poisoning and other metal-related injuries.
In 2010, DePuy recalled its Articular Surface Replacement (ASR) Hip Resurfacing System and ASR XL Acetabular System total hip replacement after a growing number of serious side effects. Some studies showed that up to 12 percent of ASR patients and 13 percent of ASR XL patients needed a second hip replacement surgery, called revision surgery, within five years of the first implantation. Other studies show up to 40 percent of ASR devices fail within the first five years. Hip implants should last up to 20 years.
Hip Implant Failure
In most cases, all-metal hip implants have a design flaw that causes a catastrophic failure. The metal pieces rub together, causing metal ions to be released into the blood stream. This causes the body to launch an immune response that can lead to swelling, pseudotumors and allergic reactions. The metal components can become loose and may cause cobalt and chromium poisoning.
To get these devices on the market, hip device manufacturers utilized the U.S. Food and Drug Administration’s (FDAs) 510(k) premarket notification process, which allowed them to skirt valuable premarket testing rules and requirements. Instead, the companies guaranteed that the devices were similar in design to ones already on the market. The problem with that is that the ones already on the market were not made from metal, instead from plastic and ceramic.
Help with Filing a Hip Replacement Lawsuit
If you have a metal hip implant or suspect you have a metal hip implant, you should first call your doctor’s office. It is possible that your components may be listed under different product names. Your doctor will want to run blood tests to ensure you are not suffering from metal poisoning or other problems associated with such devices.
If you need help identifying your devices, our patient advocates can help. They can also help you determine your best legal options.
- Meier, B. “Maker Aware of 40% Failure in Hip Implant.” January 22, 2013. The New York Times. Retrieved by http://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?pagewanted=all
- U.S. Food and Drug Administration. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems.” July 6, 2012. Retrieved from http://www.fda.gov/Safety/Recalls/ucm311043.htm?source=govdelivery