Hip replacement systems are important to so many people who struggle with pain and lack of mobility because of joint damage. An artificial hip can mean the difference between being housebound and living a normal lifestyle. Many companies make hip components and complete hip systems and over the years they have redesigned these artificial hips in an attempt to make the stronger, more durable, and to give better range of motion to patients.
Unfortunately, many newer products have failed early, caused more damage and pain, and led to numerous revision surgeries for affected patients. Hip replacement recalls have followed, with some companies voluntarily recalling their hip systems and components. If you have received a hip replacement, you need to know about these recalls and what steps to take if your hip fails or you find out your model has been the subject of a recall.
How Hip Replacements Work
Artificial hips are used when a patient has enough damage in the joint to cause significant pain and lack of mobility. Damage to the hip joint that leads to a replacement is most often caused by arthritis, but other conditions like bone cancer, or even injuries, can cause enough damage to require a new hip. In the past, hip replacement surgery was reserved for older patients who would not be very active and would not need their artificial hips to last very long. Today, artificial hip joints have been designed to last longer and to stand up to more activity so that younger patients who need one can get a hip replacement.
Artificial hips may be complete systems in which most of the natural joint is removed and replaced or components, replaced as needed. The hip joint consists of the ball or head of the femur, the thighbone, which fits into the acetabulum, or the cup on the pelvis. Artificial hips include a cup that fits into the acetabulum like a liner, a new ball for the head of the femur, and a stem that attaches the ball to the bone. Artificial hip components may be made of any combination of plastic, ceramic, or metal.
Problems with Metal-on-Metal Hips
As medical device companies attempted to design new, more durable hips for younger or more active patients, the overwhelming design was to use all metal components. Metal, it is assumed, would give the joint a greater range of motion, but would also be stronger, and would last longer without failing. There was a lot of hope for these metal-on-metal hips, but many of them turned out to cause more harm than good and led to a number of hip replacement recalls.
In 2012, amid numerous reports of metal-on-metal hip failures, more than with other types of hips, the U.S. Food and Drug Administration (FDA) took action to investigate. By 2013 the agency had released a safety warning about these hips. The announcement stated that these hips have a particular problem. The metal ball rubs against the metal cup causing pieces of metal to come loose. These fragments can cause bone and tissue damage, and even metal poisoning in some cases. Consequences include a joint coming loose or slipping out of place, pain, loss of mobility, infections and inflammation, and a need for revision surgeries to correct damage.
Some of the metal-on-metal hips have proven to fail more often than others or to cause a reaction to the metal fragments, called adverse local tissue reaction (ALTR), in the area around the hip. These joints made by certain manufacturers have been the subject of recalls. Unfortunately for some patients, the recalls came too late and they suffered pain, extra surgeries, and in some cases, permanent damage.
Stryker Hip Recall
Stryker is one company that makes hip replacement systems and components and which has come under fire for faulty metal-on-metal hips. Specifically the company’s ABG II and Rejuvenate hips have caused serious problems for patients. These hips were found to corrode and fret more than is normal, which causes a significant amount of metal fragments to break free and cause ALTRs and other problems.
In 2012 Stryker issued a safety warning to surgeons and hospitals, stating that the two hip systems were causing more ALTRs than other types of hips. The Rejuvenate and ABG II hip systems also led to more revision surgeries than is normal for most artificial hips. Shortly after the announcement and warning, Stryker initiated a voluntary recall of its two problem hips.
DePuy Hip Recall
DePuy is the maker of several hip systems including the Articular Surface Replacement, or ASR, Hip Resurfacing System and the ASR Acetabular Hip System, both of which were recalled in 2010. These hips were only sold overseas, but like many of the metal-on-metal hips used in the U.S., were found to have high failure rates and to cause ALTRs in too many patients.
Safety data from the United Kingdom led DePuy to make a voluntary recall of these two hip systems. The data showed that 29 percent of patients receiving one of these hips required a replacement within six years, a failure rate deemed too high. The overall failure rate for all artificial hips is much lower.
Smith & Nephew Hip Recall
Smith & Nephew manufactured a hip called the R3 Acetabular System, which came out in 2007 in Europe and 2009 in the U.S. After many people received the hip, it was found that the metal liner used to replace the acetabulum, was faulty. The component was prone to coming loose, moving out of place in the pelvic bone, and causing metal poisoning and local area reactions.
The metal liner caused many patients significant pain when it failed and led to a lot of revision surgeries. The company, like others on this list, had marketed its latest metal-on-metal hip as durable and long-lasting. For too many patients the opposite turned out to be true and a recall was issued. Thousands of patients received this hip system before it was recalled.
Zimmer Durom Cup Recall
Zimmer’s Durom cup, the metal liner used in the acetabulum was recalled in 2008. It was a voluntary recall over the fact that the device came with inadequate instructions for the surgeon. Although this was the reason given for the recall, there was another very serious issue with the metal liner. The surface that attached to the bone did not adhere well and slipped out of place in many patients. This led to pain, tissue and bone damage, and multiple revision surgeries for many patients.
If Your Hip is Recalled
There is a potential that even more hip systems and components will be recalled in the future. If you have a metal-on-metal artificial hip, you need to be aware of the recalls and know what to do if yours is found to be problematic. Before you sign any documents because of a recall, speak with a lawyer. The company is likely to ask you to sign away any rights to claiming it was liable or negligent for your injuries.
Some recalls come with compensation, but this is often limited. A lawyer can help you decide if you have a case to make and if you have a good chance of getting better compensation if you file a lawsuit against the manufacturer. Let someone with legal experience guide you and help you get the most for your pain and suffering.