Stryker Corp. is a manufacturer of medical devices, including artificial hips. The company makes billions of dollars on its products each year, but sometimes those products fail. The Rejuvenate and ABG II hip systems, in particular, have been found to put patients at serious risk of complications, including local reactions, inflammation, and even metal poisoning due to excessive corrosion of the components.
Although the U.S. Food and Drug Administration (FDA) received many complaints and reports of adverse events with the Stryker hips, the agency did not have to issue a recall. The company issued its own voluntary recall of these hip systems in 2012. Patients who suffered because of the hips and their premature failure have filed several lawsuits against Stryker. They hope to come to terms and to get a settlement from the company. If you have been adversely affected by Stryker artificial hips, you too could file a suit and seek the compensation you deserve.
Hip Replacement Surgery
Hip replacement surgery is a procedure that removes all or part of a hip joint and replaces it with synthetic components. These may be made of ceramics, plastic, or metal. When the entire hip needs to be replaced, an artificial hip system is surgically implanted. The natural hip joint consists of a socket on the pelvic bone, in which is situated a ball at the top of the femur, or thigh bone. This simple structure gives the joint its range of motion.
Artificial systems usually have three parts: the artificial socket, the ball, and a stem to connect the two. There may also be a neck that connects the ball to the femur. Not all hip surgeries replace the entire joint. In resurfacing surgery, the surgeon is able to save undamaged parts of the ball or socket by scraping away the damaged parts. Those resurfaced parts of the bone are then covered with synthetic components. Revision is another type of hip surgery, which is used to correct or replace an artificial hip that has failed.
Candidates for Hip Replacement Surgery
Several decades ago hip replacement was largely used on older patients. Artificial hips were not advanced enough and not durable enough to be used in younger patients who would need the joints to last for many years and through a lot of physical activity and wear and tear. Today, newer hips are stronger, last longer, and can withstand more activity, so young and old patients alike may have hip replacement surgery if necessary.
Hip replacement surgery is done when a patient has severe enough pain or lack of mobility in the hip to affect daily life. The surgery is major and risky, so it is done when the new hip will make a big impact on quality of life. Conditions that may lead to enough damage to warrant a hip replacement include osteoarthritis, rheumatoid arthritis, osteonecrosis, bone cancer, and damage or injury to the joint. Osteoarthritis, or the arthritis associated with aging, is the most common reason for hip replacements.
Risks and Complications
Any major surgery carries certain risks, some serious. A patient may have a bad reaction to anesthesia. Surgery can lead to infections, excessive bleeding, heart attacks, the formation of blood clots, and strokes. The risks have to be weighed against the benefits of getting a new hip. In addition to the risks of surgery in general, hip surgery can lead to deep joint infections, bone loss, nerve damage and weakness or numbness, legs of different lengths, breakage or loosening of the artificial joint, swelling, inflammation, and pain.
Metal-on-Metal Hip Systems
Some of the newest artificial hips are made of all metal components. These are the designs that are supposed to be more durable and long-lasting than ceramic or plastic hips. There are some problems with these hips, though, including the Stryker models. The FDA has issued several safety warnings about the risks of toxic metals getting into the bloodstream with metal-on-metal hips.
Because all components of these hips are metal, when one rubs against the other during normal movement, small fragments of the metal wear off and can enter surrounding tissue and the bloodstream. Not everyone will have a bad reaction to this phenomenon, but some may experience metal poisoning with symptoms like headaches, fatigue, stomach upset, kidney damage, dizziness, a weakened immune system, and nervous system damage. Metal poisoning can cause memory and cognitive problems and even cancer.
Some patients also react badly to the metal hip right in the vicinity of the joint. This localized reaction can cause inflammation, pain, and loosening or shifting of the artificial joint. These issues most often need to be corrected with revision surgery. The FDA suggests that patients with metal-on-metal hips get regular X-rays and blood tests to screen for problems before symptoms arise.
Stryker Rejuvenate and ABG II Hip Systems
Two of Stryker Corp.’s artificial hip systems, the Rejuvenate and the ABG II, have more problems than most metal-on-metal hips. They were found to corrode and fret, causing metal to get into the nearby tissues, blood, and even the bone. Several patients experienced serious localized reactions to the hips, including death of tissue and bone near the joint and the failure of the joint itself.
The localized reaction is called adverse local tissue reaction, or ALTR. Stryker sent out a communication in 2012 to warn surgeons that their hips caused more ALTRs than other kinds of hips, as evidenced by post-market clinical data. The notification included this warning as well as a warning about the potential for fretting and corrosion of the hips once in place, metal poisoning, necrosis, or tissue death around the hip joint, allergic reactions to metal, and osteolysis, or bone loss, caused by metal fragments. All of these issues were found to occur at an increased rate with the Rejuvenate and ABG II hips.
Shortly after sending out the safety warnings in 2012, Stryker voluntarily recalled its problematic hip systems. The FDA had already received a number of reports of adverse events occurring with the hips, so a forced recall may not have been far off for Stryker. The company had previous recalled other hip systems and components due to high rates of revision surgeries, packaging errors, and manufacturing mistakes.
The failure rates, local reactions, and the corrosion and fretting that cause metal to seep into other tissues and the bloodstream, have caused serious complications for many patients who received a Rejuvenate or ABG II hip system. Many have suffered pain and immobility and have had to have second, third, and even fourth revision surgeries to correct the problems. Some of these patients have also filed lawsuits against Stryker to attempt to recover monetary damages for their pain and suffering.
These suits say that Stryker was negligent in that it did not adequately warn patients and doctors about the serious risks of their hip implants. The company may have known about the risks earlier and failed to communicate them to doctors and the public. The plaintiffs also accuse the company of making false claims about the safety of the metal used to make the hips. If you have received one of these Stryker hips and suffered serious complications, let a lawyer help you figure out your options for filing a lawsuit.