Stryker Corp. is a large company based in Kalamazoo, Michigan with several divisions all in the area of medical technology. The company designs, develops, makes, and sells surgical equipment, endoscopes, emergency medical equipment, spinal devices, specialty medical devices, and joint replacement systems. The orthopedic division makes knee, hip, and elbow joints, all of which have caused complications in patients.
Although Stryker has been in business for decades and has created a number of medical innovations, the problems with some of its joints have led to serious problems. Some of these have resulted in recalls, lawsuits, and settlements. If you have been damaged or hurt by a Stryker joint implant, you too could become a part of the settlements and get the compensation you need.
Stryker – Overview
Stryker Corporation is a U.S.-based global medical technology company that designs and makes a wide variety of medical devices. The company markets these devices directly to hospitals and doctors and sells them in over 100 countries. The main divisions of Stryker focus on medical and surgical devices, neuro-technology, spine care, and orthopedics. Revenues for Stryker have grown nearly every year for decades, with close to $10 billion in sales in 2015.
It is Stryker Orthopedics that makes the joint implants that have caused problems for the company, although overall Stryker has seen mostly success. The orthopedics division makes artificial joints and joint components for hips, knees, shoulders, elbows, feet, and ankles. Because of failures with some of these joints and a large amount of revision surgeries, Stryker has faced recalls, lawsuits, and settlements.
The history of Stryker begins with an orthopedic surgeon, Dr. Homer Stryker, of Kalamazoo, Michigan. He started the company in 1941 to produce better medical products after being dissatisfied with what was available to him for use with his patients. He wanted to create products with better designs that would make surgery simpler, recovery faster, and the lives of his patients better and more active.
Dr. Stryker began his company more as a hobby, designing products in his basement. Eventually demand for his products grew and the company became official in 1946, first named the Orthopedic Frame Company. Some of his original products included a cast cutter, a cast walking heel, a traction device, and a turning frame for surgical beds. The business really took off during World War II as demand for medical products soared.
Stryker Orthopedics began in 1998 when Stryker Corp. bought the orthopedics division of Pfizer. Since that time, Stryker’s presence in the orthopedics industry has grown steadily with new inventions and more acquisitions. By 2010 the company had 25 percent of the U.S. market on artificial hips and knees being sold to hospitals, doctors, and other health care facilities.
Artificial hips are a big part of Stryker Orthopedics. The company has designed a number of innovative lines of hip joints and components and they make up a major segment in the U.S. two particular hip systems, however, have caused some serious problems. These include the metal-on-metal Rejuvenate and ABG II systems. Metal-on-metal hips were supposed to be more durable to last longer for younger and more active patients, but problems were seen almost immediately.
One serious issue is the fact that when the metal surfaces of the joint rub together, they release tiny fragments of metal into the patient’s tissues and blood, which can cause irritation, infection, and metal poisoning. Some people react more than others to metal and some have very serious reactions. Artificial hips are made of three basic parts: a cup or socket, a head attached to the femur, and a stem that connects the two. The head and cup rub together when the joint moves, causing the wear and release of metal particles.
Stryker issued a warning in 2012 that its two metal-on-metal hip systems could cause reactions from the metal fragments more often than other hips. Reports of reactions included allergic reactions and metal poisoning, and even bone loss and tissue death. These issues led to a number of revision surgeries for many patients who had been given the affected hip systems. Soon after releasing the warning, Stryker voluntarily recalled its problem hips.
Stryker also makes artificial knee joints and components and has had issues with how they have been manufactured. Specifically, a 2007 warning from the FDA was issued with regards to manufacturing at facilities in New Jersey and Ireland. The warning stated that two of the knee components coming from these plants, called the Scorpio and the Duracon did not meet manufacturing standards. The company has also had to recall some knee components, including the EIUS Unicompartmental Knee Systems, because they led to high revision rates.
Stryker also faced issues with its OtisKnee, an artificial knee made by the OtisMed unit of the orthopedics division. The company was accused of and pleaded guilty to selling these devices before they had been approved by the FDA. Stryker admitted to selling 18,000 custom knee devices without approval and ended up paying $80 million in federal and civil fines.
Yet another recall faced by Stryker occurred in 2015 related to elbow implant components. Those recalled by the FDA include the uHead, Sigmoid Notch, Radio Capitellum, Remotion, and rHead. The class II recall was issued because it was found that the sterile barrier in the packaging of the components could be broken during transportation. This would put patients at risk of infection. Around 17,000 of the components were included in the recall.
In addition to the federal criminal and civil suits Stryker faced because of the OtisKnee, the company is also looking at lawsuits from individuals harmed by the hip joints. Stryker is facing lawsuits over its Rejuvenate and ABG II hip systems from patients who had bad reactions to the hips and required multiple revision surgeries to heal. These patients accuse the company of knowing about the risks of their hips and not communicating them to doctors and patients. They also state that Stryker made false claims about the metal used in the hips.