Approximately 130,000 knee replacement surgeries are performed every year in the United States. Too many of these knee replacements in recent years have had defective hardware. Smith & Nephew's Journey knee replacement did not fare well.Background
The knee is the largest joint in the human body. The knee joint supports the majority of the body’s weight, and as a consequence is susceptible to injury or trauma with the development of osteoarthritis in later life. Knee replacement surgery is often necessary for patients with osteoarthritis to alleviate pain when non-surgical therapies are ineffective.
An estimated 581,000 knee replacements are performed annually in the US. Direct costs of hip and knee replacements are greater than $35 billion. Is there a battle over that money by companies fighting to get to that market as quickly as they can? You bet. This number is growing, too. By 2030, it is projected that total joint replacement will increase to 4 million patients annually.
Knee revisions are very complicated devices. They have a lot of parts and instruments. There are over 300 separate instruments that need to be tested and validated to be confident the knee will perform as anticipated. There is also a lot that can go wrong.
Various knee replacement devices are available and used in practice including polyethylene, metal, and ceramic knee replacement devices. First-generation knee implants were polyethylene, however, over time, these devices proved to be sub-optimal.
As a result, manufacturers turned to metal-backed designs cemented to the tibia, and more recently cementless designs. Manufacturers continue to research and bring to market devices that have lower rates of dislocation and increased longevity of the implant. Factors that impact long-term outcomes include the type of device implanted, the surgical technique, and patient factors including activity, age, gender, body mass, etc.How Do Knee Implants Work?
Knee replacement surgery is a frequent choice for patients who are at their wits end from arthritis or extensive fractures. These patients did not want surgery but they just ran out of options. The following are the most common indications for surgery:
- Arthritis: this is inflammation of the knee joint which causes wear and tear on the knee cartilage.
- Osteoarthritis: this is the most common type of knee arthritis, and results in bone-on-bone contact at the knee joint.
In a total knee replacement surgery, surgeons remove the bone and cartilage on the end of the femur (thigh bone) and the shin bone (tibia). Devices, historically made of plastic but now more frequently, metal, are then attached to the bones to give the patient a new knee joint.What Is Wrong With Smith & Nephew Implants?
Smith & Nephew promote their Journey knee devices as a device that potentially lasts longer than similar devices due to a lower rate of wear. Their faulty knee replacement implants use oxidized zirconium rather than cobalt chrome or titanium which are more commonly used in replacement devices. Studies have shown that as cobalt devices wear, particles are released which can result in inflammatory reactions.
Plaintiffs' attorneys at first zeroed in their attention - and lawsuits - on Zimmer knee replacements This led both lawyers and researchers to take a closer look at knee replacements generally. There reviews were not good. What was found is that these new knee replacements are inferior, including the Smith & Nephew knee replacement.
How did these knee replacements get on the market? Good question. Many joint replacement devices receive regulation under the 510(k) notification program. This FDA program allows medical devices to enter the market without requiring manufacturers to conduct clinical studies. Instead, the manufacturer must only demonstrate the device is substantially equivalent to other similar products already on the market. So the actual product that goes into a patient's knee is not tested like these medical devices should be tested.
The FDA announced a Smith & Nephew recall of nearly 40,000 defective tibial baseplates in January 2010. An Alabama man filed a lawsuit against the manufacturer after receiving a knee replacement in 2008 which included a Journey tibial baseplate. The baseplate broke within 2 years of the replacement surgery.
Now many other suits have followed against Smith & Nephew including one alleging that a lateral proximal tibia locking plate was defective and broke within 6 months of implantation and another case where Journey knee components completely failed within a year and a half, resulting in revision surgery.
Smith & Nephew has a troubled history with these knee replacements. Previously in 2003, Smith & Nephew recalled their cementless knee replacements (Oxinium Genesis II and Profix II devices). The recall was prompted when the manufacturer discovered a design flaw that did not allow proper bonding of the bone in its cementless design, leading to a loosened joint, failure, loss of range of motion, infection and increased pain. By 2005, 26% of these implants required revision surgery. Similar cementless devices have raised concerns due to failure including Zimmer devices.
As the population ages, this is only going to get worse. There will be more and more joint replacement surgeries with orthopedic implants leading the way. We just have to hold the makers of knee replacements accountable.
A starting point? Conducting properly designed clinical trials to determine the safety and well-being of patients receiving these implants. This is a critical step that needs to be taken to reduce the necessity for revision surgery and, in turn, alleviate the associated burden on the healthcare system. Will it happen? I think the question hinges on how successful these knee replacement lawsuits will be. Are we going to make these device makers make sure they get it right?The Future
Smith & Nephew has launched its new and improved knee, the Legion HK hinge knee implant. It is supposed to mimic the knee's natural functionality in a whole new way, transforming a knee replacement from a salvage operation to a full joint rescue. Will the Legion live up to this promise? Maybe it will. But that does not change the suffering that has been endured from the problems with the Journey knee.
Our lawyers are no longer handling Smith & Nephew knee replacement claims. We leave this page up because when attorneys take their pages down, they take down a ton of information that still matters to victims.