A Patient’s Guide To Recalled Metal-On-Metal Artificial Hip Implant Models
People who need hip replacement surgeries are placed in the difficult position of choosing which artificial device will give them the greatest amount of mobility in later years. Artificial hips can be made of ceramic, plastic, or metal, and are frequently molded with a combination of all three materials. Some manufacturers have released hips that have a metal cup and a metal stalk, allowing both parts of the ball and socket joint to be as strong as possible. But in recent years, these metal-on-metal designs have exhibited signs of early failure and dangerous side effects, forcing companies to recall the devices.
How Serious Is the Metal-On-Metal Hip Recall?
Medical device recalls are initiated one of two ways: either the manufacturer can voluntarily recall a device, or the U.S. Food and Drug Administration (FDA) can order the manufacturer to recall it. Each recall is classified according to the severity of injuries posed by the device:
- Class I: A class I recall poses the greatest potential for danger to consumers, and can result in situations that cause serious bodily harm, ill health, or even death.
- Class II: Products in a class II recall have a small chance of causing harm, which is usually temporary or can be effectively treated medically. The majority of recalls are in the class II category.
- Class III: These recalls are issued where there is a defect in a product that has been acknowledged, but is unlikely to cause harm.
The metal-on-metal hip implant recalls are worrying for a number of reasons. First, affected patients cannot “return” their devices as easily as swapping out an auto part or child’s toy; they need to undergo further surgery. Second, any injuries caused by the devices might not be reversed by replacing the affected hip. Finally, the money companies set aside to compensate consumers in a recall often doesn't cover the full costs of a patient’s injury, which can include loss of income, pain, and ongoing medical treatments.
Recalled Hip Implants Include Stryker, DePuy, and Wright Devices
As of 2013, Stryker recalled over 200 models—a number slightly higher than recalls for manufacturer DePuy. People have suffered metal poisoning, broken bones, debilitating pain, and more as a result of the following implants:
- DePuy (ASR XL Acetabular System). The FDA’s class II recall of these hip systems was two months ahead of the company-initiated recall in 2010, following reports of toxicity and the release of metal debris into the body. Injuries from the DePuy ASR hip implant reportedly cost the company over $800 million.
- Stryker (Rejuvenate Modular and ABG II Modular-Neck Hip Stems). Stryker issued a voluntary recall of the Rejuvenate and ABG II hip systems just three years after the devices were put on the market. The recall came on the heels of an urgent field safety notice issued by the manufacturer, alerting doctors and hospitals to the risk of adverse local tissue reactions due to particle shedding in the devices.
- Zimmer (Durom Acetabular Component, Zimmer M/L Taper with Kinectiv Technology).The FDA issued a class II recall of Zimmer’s Durom Acetabular Component (known as the Durom Cup) in 2008 due to reports of premature failure, affecting over 19,000 implanted patients nationwide. In June 2015, the FDA issued a class I recall of the Zimmer M/L Taper with Kinectiv Technology when the agency discovered higher than acceptable levels of manufacturing residues left on the devices prior to implantation.
- Wright/MicroPort Orthopedics (Profemur Z Hip Stem, Profemur Neck Varus/Valgus CoCR). Wright Profemur hip defects included corrosion in the hip joint, fretting, and femoral neck fractures. The dangers prompted the FDA to issue a class I recall of the Profemur Neck Varus/Valgus CoCR, citing the devices probability to cause significant “adverse health consequences.”
- Smith & Nephew (R3 Metal Liners of the R3 Acetabular System). Smith & Nephew introduced its R3 Acetabular System to the U.S. market in 2009, and over 3,000 Americans were implanted with the device and its optional metal liner. While the metal component was marketed as making the device more durable, Smith & Nephew later admitted that the lining suffered from performance issues. The company initiated its own recall of the devices in 2012 due to growing reports of sudden loosening and dislocation of the implant.
We Can Help
If you had revision surgery after being implanted with an artificial hip, we can help you get fair compensation for your suffering. The McGartland Law Firm helps patients nationwide recover from medical device injuries, and we don't collect any legal fees unless we win your case. Contact us today to have us begin an investigation into your claim.