What to Know About the 2012 Stryker Hip Implant Recall
In July 2012, Stryker Corporation issued a Class 1 recall of its Rejuvenate and ABG II hip implant models. Stryker voluntarily recalled its products after numerous reports of patient injury and implant failure that required painful revision surgery to correct. In 2008, Stryker was forced to recall its Trident PSL and Hemispherical Acetabular Cup hip implants, making the 2012 decision the second time in four years that the company has been forced to pull a dangerously defective hip replacement product off of the market.
Stryker Hip Implants Released Without Testing
Both the Rejuvenate or ABG II hip implant models were released onto the market without clinical tests. Typically, the Food and Drug Administration (FDA) requires medical devices be tested so doctors and manufacturers are aware of any potential side effects that could arise during regular usage. However, Stryker was able to avoid premarket testing under the 510(k) exception to FDA rules which allows for a product to be released without testing if it is similar to a product that is already on the market.
The market for medical devices is highly competitive with several manufacturers attempting to release the next innovation as quickly, and cheaply, as possible. Premarket testing can cost millions of dollars and take months to complete, so it is common that companies like Stryker will utilize the 510(k) exception to significantly reduce the cost of releasing a new product and the time it takes for one to hit the open market. The result in Stryker’s case was detrimental to patients who suffered ongoing pain, extensive revision surgery, and potentially serious effects on their health caused by unknown dangers associated with Rejuvenate or ABG II hip implants.
Painful Defects of the Stryker Rejuvenate and ABG II Hip Implants
Stryker’s Rejuvenate and ABG II hip implant models were considered upgrades because the company avoided using a metal-on-metal design in which a metal ball rubs up against a metal socket. What the company did not expect was that the metal neck (the long piece that runs down the femur) and the metal stem (closer to the hip joint) would rub together and release metallic fragments into the surrounding blood and tissue.
When metal components release metal ions into the blood and surrounding tissue, patients face a risk of a condition known as metallosis. Metallosis is an adverse reaction by the body to the metallic fragments, and its effects are not fully understood. It is known that metallosis causes pain, limits mobility, and leads to premature tissue death and bone dissolution. The condition potentially causes tumor formation, but it is uncertain whether those tumors are cancerous at this time. Regardless, it is certain that increased metal toxicity levels in the body are unhealthy, and the latest Stryker hip implants present serious health risks.
The effects of metallosis are not always immediately apparent, so a patient who has had a Stryker hip implant installed should consult their doctor. The condition can have a hazardous effect on a patient’s health, so it is important to act quickly in order to prevent serious problems. If you are unsure if your hip implant is manufactured by Stryker, you should contact doctor.
Stryker Hip Implants Require Corrective Surgery
Unfortunately for patients, the only way to correct the problems created by the Stryker hip implant models is to undergo painful revision surgery. With the problems caused by the Rejuvenate and ABG II models occurring in the neck and stem area, only a complete replacement of the implant can correct the defect. Surgeons must cut along, and often break, the femur to remove the neck of the hip implant. This type of surgery will cause a patient significant pain, and will increase the length of time required to rehabilitate.
Stryker Hip Implant Lawsuits
In the wake of the recall of Stryker’s Rejuvenate and ABG II hip implants, patients who have suffered injury and gone through painful corrective surgery have begun consulting attorneys and filing lawsuits. An experienced attorney can help patients recover the damages they are owed in compensation for their injuries, so it is critical to seek out the help of a lawyer familiar with Stryker litigation.
Check out the following articles for more information about Stryker Hip Implants, filing a Stryker Hip Implant lawsuit and finding a Stryker Hip Implant attorney.
- For more information about Stryker Hip Implants, see Stryker Hip Implants: Overview & Claims.
- For more information about Stryker Hip Implant problems, such as pain, squeaky joints and/or bone fractures, see Stryker Hip Implant Problems: Pain, Squeaky Joints & Bone Fractures.
- If you would like to learn more about Stryker Hip Implant lawsuits and see how an attorney can assist you, see Stryker Hip Implant Lawsuits, Litigation & Lawyers.