Stryker Hip Implants
Stryker Orthopaedics is manufacturer of medical devices including two hip implant products, the Rejuvenate and the ABG II systems.Both of these systems use metal components, and, like all products in this class of medical devices, health issues can develop as a result of the breakdown of metal parts in the body. As modular systems with unique designs, Stryker hip implant devices also have additional problems that many metal-on-metal implant systems do not have.
Between 2009 and 2012, around 20,000 ABG II systems and Rejuvenate devices were implanted in patients who needed hip replacements. The products were especially targeted to younger, more active people who wanted a greater range of motion than traditional hip implant products offered and who were hoping for a longer life of their joint replacement device.
Unfortunately, Stryker’s hip implant devices began causing serious problems very quickly for patients who had the Rejuvenate or ABG II systems implanted. Many patients needed surgery to correct failures and suffered ill health effects due to metal debris in the body. Stryker recalled the two products in July 2012, and lawsuits have already been filed against the manufacturer to obtain compensation for damages.
If you have suffered adverse consequences from a Stryker hip implant, the defective medical device lawyers at Roberts & Roberts can provide you with a free confidential review of your potential claim.
Stryker Hip Implant Systems
The hip joint consists of the acetabulum, which is a concave indentation in the pelvis that the joint fits into, along with the femoral head (the top of the femur).In a hip replacement, a new joint is attached to the top of the femur and a cup is placed inside of the acetabulum for the new joint to slide into.
Traditionally, the cup that fit into the acetabulum was constructed of a polyethylene (plastic) material and the replacement joint on the femoral head might consist of a ceramic or metal joint. In the mid-2000s, however, many manufacturers began to bring new products to the market called metal-on-metal hip implants, with both the acetabular cup and the replacement joint made of metal.
These products came to the market under 510(k) rules, a provision in the FDA rules that allows for a drug company to market a product that is substantially similar to devices already approved without conducting the testing that would otherwise be necessary. Stryker’s Rejuvenate and ABG II systems were two products that were approved under 510(k).The Rejuvenate system got approval in June 2008 and the ABG II system got approval in November 2009.
Unfortunately, Stryker’s devices had a host of problems that were unique to their design. Unlike most hip implant systems, Stryker products had multiple components that fit inside of the femur to hold the replacement joint in. Most systems had just one “stem” that fit inside the carved-out femur. Most systems also had a one-piece neck atop the femur. The ABG II system, on the other hand, had eight right stems, eight on the left, and 10 modular necks. The Rejuvenate system had six stems and a total of 16 necks.
The stems were made of metal, including titanium, circonium, molybdenum and iron. They were supposed to be more flexible since surgeons could custom fit the new stem and neck to each individual patient.Unfortunately, this still resulted in metal components that rubbed against each other, just like in metal-on-metal hip products. As a result, although the Stryker devices don’t have a metal joint fitting into a metal cup, they still cause problems with metal breaking down in the body.
When the metal components of the Stryker systems start to rub against each other and metal debris comes off, a variety of complications can develop, including:
- Necrosis — Death of tissue in the body
- Metallosis – A toxic buildup of metal ions.The FDA warns that metallosis can affect the nervous system, thyroid gland and heart, while the British Medical Journal warns of damage to the kidneys, muscles, liver and lymph nodes.
- Osteolysis — A breakdown of the bone. The American Academy of Orthopedic Surgeons has cautioned that the number of patients needing surgery to correct this problem may double over the next 5-10 years due to the problems with hip implant and replacement products.
- Pseudo-tumors –A tumor-like collection of metal flakes and fluid
- Bone fractures due to poor fixation of the hip implants.
Revision surgery is almost always required, and the procedure of removing and rebuilding the hip joint can be extensive. In some cases, the adverse consequences caused by the Stryker devices and the buildup of the metal components in the body cannot be reversed, leaving patients with ongoing diminished quality of life.
Legal Help for Stryker Hip Complications
The dangers of Stryker hip implants have been well established by studies and adverse reaction reports. In November 2007, the FDA issued a written warning to the manufacturer, accusing the company of using faulty parts and failing to meet quality-control standards. In the warning, the FDA admonished Stryker that complaints of problems had been coming into the administration since 2005 and that the company had not acted effectively to resolve the problem.
Due to the mounting concerns and the growing number of adverse claims, Stryker recalled both the Rejuvenate and ABG II hip implant systems on July 6, 2012. This recall came too late for many of the patients who have already developed complications and who have undergone painful corrective surgeries.
If you or a loved one has been injured as a result of a hip implant device made by Stryker, you could be entitled to compensation.
At Roberts & Roberts, our experienced defective hip implant attorneys help patients get the money they deserve to compensate them for their losses. For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.