Coming only a few years after recalling its Trident PSL and Hemispherical Acetabular Cup hip implants products, the Stryker Corporation is once again pulling products off the market. After complaints of implant failures, and reports of negative health side effects, Stryker has issued a voluntary recall of its Rejuvenate and ABG II hip implant models.
Stryker’s Latest Models Avoid Clinical Tests
Stryker most recent recall is pulling its Rejuvenate and ABG II products out of circulation. These models were pushed through an abbreviated testing phase under a regulation that allows for fast-track approval if the model is “substantially similar” to a model that has already undergone clinical testing. Known as 510(k) Premarket Notification, the FDA’s rule on bypassing testing for new products that compare to existing ones allowed Stryker to push its Rejuvenate and ABG II models onto the market before testing could reveal the potential side effects.
Premarket testing can cost millions of dollars and take months to complete, so Stryker, and many other hip implant manufacturers such as DePuy and BioMet, utilize the 510(k) testing exception. When a medical device is released onto market without premarket testing, the testing occurs during “post-market surveillance,” which means that the products are monitored for potential defects after being used in patients. Releasing the Rejuvenate and ABG II models onto the market without testing may have contributed to the Stryker’s ignorance of the side effects, and could open the door for injured patients to receive additional damages.
Deficiencies Causing the Rejuvenate and ABG II Recall
After installing the latest Stryker hip implant products, doctors and patients began to notice failure requiring revision surgery after less than 2 – 3 years of use. The cause of the failure appears to be that the Rejuvenate and ABG II models have a metal-on-metal junction of the neck (the long piece that runs down the femur) and the stem (closer to the hip). In the Styker hip implants, the neck and the stem both contain metal components, and the junction of the two allows for scraping that releases metal into the body.
When metal parts of a hip implant scrape together, patients have an increased risk of a condition known as metallosis, which occurs when fragments of metal enter the body tissue around the hip joint. Metallosis is an adverse tissue reaction to the metal in the body, and can cause pain, limited mobility, and failure of the hip joint. This problem was unexpected, as neither the Rejuvenate or ABG II models were designed with metal on metal contact.
In many cases, it is difficult for a patient to know if they are suffering from metallosis until they start experiencing pain in their hip and surrounding area. Further, the possible effects of metallosis are not fully known, and can take root even before the patient notices discomfort or pain in the area. Even patients who have not experienced pain associated with their Stryker hip implant should consult a doctor. The 2012 recall indicates there are serious problems with the Stryker Rejuvenate and ABG II models that can only be corrected by removing the implant and replacing it. While the surgery is painful, it is important that patients with Stryker hip implant models consult a doctor about the risks they face with the Stryker models.
Repairing the problem with Stryker hip implants can be a serious and painful operation. With the problem arising at the junction of the neck and the stem of the implant, surgeons must cut along the femur, oftentimes breaking it, in order to remove the problematic component. Because of the particular defect, patients suffering from defective Stryker models must face not only the problems the hip implants cause, but face a painful revision procedure that further complicates their recovery.
New Stryker Hip Implant Lawsuits
Lawsuits have already been filed against Stryker for injuries related to the models recalled in 2012. After gathering information about the Rejuvenate and ABG II recall, patients have contacted attorneys and begun taking legal action for their injuries.
An injured patient considering a lawsuit against Stryker should be aware of the types of damages they can include in their claim. Patients injured by the Stryker Rejuvenate and ABG II hip implants should claim the following:
- Damages for pain and suffering, which factors in the pain of additional surgeries, and the negative effect multiple hip surgeries will have later in life
- Damages for out of pocket medical costs, including additional corrective surgeries
- Damages for past, current, and future loss of wage earnings
- Punitive damages because the product bypassed premarket testing under the 510(k) exception
An experienced attorney will be able to explain how to calculate these damages, and help gather evidence in preparation for a lawsuit. An injured patient considering litigation should document every cost and loss associated with the injuries caused by a Stryker hip implant. There are several different types of damages available to patients filing a Stryker hip implant lawsuit, so everything needs to be properly documented.
If you or a loved one has experienced problems with Stryker’s Rejuvenate and ABG II models, contact an experienced attorney who can handle this type of case.
2008 Stryker Hip Implant Recall
In 2008, Stryker recalled its Trident PSL and Hemispherical Acetabular Cups after testing results indicated that the products experienced the following problems after being installed:
- Trident PSL and Hemispherical Acetabular Cups cups failed to function; hip implant components have poor fixation. In some instances, these problems have required revision surgeries.
- Squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments).
- Improper seating of hip implants in broached bones resulting in bone fractures.
If you have experienced problems with the Stryker’s Trident PSL and Hemispherical Acetabular Cups, contact an experienced attorney who has been following these issues and whose practice focuses in this area of the law to discuss your options. To contact an attorney for a free, no-obligation consultation, please click here.