Stryker and DePuy Hip Replacement Devices
Have You Suffered From a Defective Hip Replacement?Hip Replacement is One of the Most Common Procedures in Orthopedic Surgery
When an individual suffers a hip injury such as a fracture, or hip pain from conditions like rheumatoid arthritis, traumatic arthritis, necrosis, or even a bone tumor, a partial or complete hip replacement may be indicated, particularly if other forms of therapy or treatment provide no or only limited relief. Because hip injuries affect mobility so severely, many people opt for the temporary discomfort of hip replacement surgery in hopes that it will provide them long term relief from pain, discomfort, or immobility.
Hip problems are most common among those over 60 years old, and, according to the American Academy of Orthopedic Surgeons, only about 10% of hip replacement surgeries are performed on those under 60. In the distant past, hip problems in the elderly were often completely debilitating, and it has been such a persistent problem that hip replacement surgery was one of the earliest targets for trying to achieve a prosthetic remedy. Finally, in the early 1960’s, a British surgeon performed the first successful complete hip replacement surgery.
One reason that most operations are performed on those over 60 is that, despite its relative success, hip replacement does not necessarily provide a permanent long term solution to hip problems, particularly for active and young individuals. Hip replacement surgery also requires an extended period of recovery, sometimes involving intensive physical therapy.
As the procedure has developed over time, medical device manufacturers have also developed various prosthetic hip devices in an attempt to create an ideal solution. Today, hip replacement is one of the most common types of orthopedic operation, with between 200,000 and 300,000 operations occurring in the United States every year.Certain Complications or Adverse Consequences are Relatively Common in Hip Replacement Surgery
Despite the frequency with which it occurs, hip replacement is not a perfected procedure.
Hips are one of the largest joints on the human body. They are ball-and-socket joints, which means they provide a greater range of movement than, for example, hinge joints, such as the knee or elbow. The socket portion of the joint is in the pelvic bone, with the ball on the head of the upper end of the femur (or thigh bone). The bone surfaces of the joint are covered with smooth cartilage, which normally allows the bones to move easily against each other without friction or pain. Unfortunately, it is very difficult to reproduce artificially this complex joint.
Replacement devices on the market have experimented with various materials in an attempt to achieve an adequate substitute for the body’s natural hip. An effective device must provide a broad range of movement, yet have enough integrity to minimize the possibility of dislocation; the device must withstand tremendous friction in the joint itself, without degradation of the materials; the joint must be strong enough to withstand body weight and the pressures exerted upon the body in walking, sitting, running, and other activities; and it must be able to integrate into the body’s natural environment without being rejected or causing other, additional physical complications.
Naturally, every type of surgery carries with it specific risks, and prosthetic device surgery is no different. When it comes to hip replacement, there are specific complications which patients are usually informed of when consulting with their physicians and surgeons. While hip replacement is relatively successful, in that over 60% of patients have experienced satisfactory results up to 25 years after surgery, there are some relatively common complaints that hip replacement patients may experience, such as:
- Inflammation of the hip bone and joint, related to the “wear and tear” on the prosthetic device. Unfortunately, tiny particles of these devices can be released into the body from friction by use, and cause complications;
- Heterotopic bone, or bone that develops between the femur and the pelvis as a result of the surgery, which can cause stiffness or pain in the hip area; there are, however, some therapies for this;
- Minor change in the length of the leg—usually lengthening the leg of the hip that has been operated upon;
- Damage to the prosthesis device, such as dislocation, which must be treated by additional surgery.
Notwithstanding these risks, hip patients welcome hip replacement surgery in the hope that it will provide them with long-term relief from chronic pain and/or limited mobility that can dramatically impact their quality of life.Serious Problems with Replacement Hips May Result in Liability for Medical Device Manufacturers
Despite some common complaints, however, sometimes there are uncommon complaints from hip replacement surgery.
In particular, as medical device manufacturers have come to recognize the ubiquitous nature of hip replacement surgery, they have naturally sought to expand their market share by introducing products that are supposedly superior to those already on the market. And while these companies are often truly interested in building a better device, occasionally, they produce devices that introduce significant and unanticipated problems that cause serious injury. And when that happens, it may be possible to hold them legally liable for the injuries they cause through a product liability lawsuit.
Product liability is a specific type of negligence suit, in which a plaintiff claims that a particular manufacturer created a product that has serious fault causing an unreasonable and significant risk of injury, such that it should not have been placed on the market. In general, product liability suits usually classify three types of potential faults:
- A manufacturing defect, in which the product was made incorrectly or used inferior or faulty materials or components;
- A design defect, where the actual design of the product carries with it certain risks; or
- A failure to warn (also known as a marketing defect), in which the product may function as intended, but carries certain risks of use which the manufacturer should warn users of in order to avoid injury.
Medical device manufacturers Stryker and Depuy manufactured hip replacement devices that have since been recalled by the federal Food and Drug Administration (FDA), giving rise to lawsuits against these companies for product liability as plaintiffs seek compensation the injuries caused by these devices. In both cases, these manufacturers produced and sold metal-on-metal hip replacement devices, and allegedly continued to do so even after there were some indications that these devices had the strong potential to cause serious injury.
In the case of Stryker, in March of 2007, the FDA issued a warning for Stryker Trident implants, finding violations of manufacturing regulations, including finding contamination from Staph bacteria within the plant. In addition to these manufacturing problems, there were problems with the device itself, including parts of the device not maintaining integrity, and the joint itself making popping and squeaking noises. Less than a year after this warning, the Stryker issued a recall not only on this device, but on other hip replacement devices manufactured by the company.
In 2010, due to increased information about metal-on-metal implants, DePuy, another medical device manufacturer, recalled its ASR Hip System hip replacement devices that had been on the market since December 2005.
In simple terms, with the specific devices manufactured by these companies, both the artificial ball and socket, or “cup”, were manufactured out of metal. As a result, the friction of the parts causes metal particles to wear off of the device, which then enters into the space near the implant. These tiny particles may affect individuals in different ways—some metal ions may cause damage to surrounding bone or tissue, causing inflammation, pain, or swelling. In addition, the wearing down of the joint may lead to loosening of the joint or dislocation. Some ions may enter the bloodstream, and lead other illnesses and complications unrelated to hip pain or injury, such as heart, thyroid, or nervous system problems.
Currently, the FDA has a notice detailing the dangers associated with metal-on-metal hip replacement devices, and has issued guidelines for patients and orthopedic surgeons dealing with these implanted devices.If You Are Experiencing Serious Complications from Hip Replacement Surgery, or if You Know that You Have a Metal-on-metal Hip Replacement Device Manufactured by Stryker or DePuy, Grimes Teich Anderson May Be Able To Help
If you had hip replacement surgery before 2010, it is important for you to find out if the hip replacement device implanted in your surgery is the subject of one of these recalls. Even if have not experienced any problems and are not experiencing any difficulties now, it is critical for you to determine whether you could be at risk of developing complications or injury as a result of a Stryker or DePuy hip device.
The product liability attorneys at Grimes Teich Anderson are experienced in helping patients recover from injuries caused by defective drugs or medical devices. If you need help, assistance, information or advice regarding a potential case involving a hip replacement device, contact Grimes Teich Anderson toll-free at (800) 533-6845, or complete our confidential case evaluation form online.*
We have offices located in Asheville, Rutherfordton, Waynesville, and Spruce Pine, North Carolina, as well as in Greenville and Gaffney, South Carolina. Give us a call for your free case evaluation.
*Grimes Teich Anderson LLP works on these cases with Henson & Fuerst PA, Raleigh NC but these claims will be handled primarily by associated co-counsel with offices in other state(s).
Stryker is a registered trademark of Stryker Corporation. Depuy is a registered trademark of Depuy Orthopaedics and of Johnson & Johnson Co.