The Stryker Corporation, a leading manufacturer of medical and orthopedic devices, marketed its Rejuvenate and ABG II Modular-Neck hip stems to younger patients, touting durable, long-lasting designs that were made to withstand the stresses of an active lifestyle.
Unfortunately, many patients who received these Stryker implants didn't gain the improved flexibility or increased range of motion they were promised. Instead, a design flaw in the Rejuvenate and ABG II Modular-Neck hip stems subjected patients to a wide range of painful side effects and complications.
Approved in 2008 under the Food and Drug Administration's (FDA) expedited 510(k) Premarket Notification Process, Stryker devices were implanted in more than 20,000 patients before reports of related side effects and complications became widespread. The 510(k) clearance process allows medical devices to bypass rigorous testing and clinical trials, as long as they are “substantially similar” to currently approved devices marketed in the United States.
In 2012, the Stryker Corporation issued a voluntary recall of the Rejuvenate and ABG II Modular-Neck hip stems devices. However, the negative effects of these faulty devices still plague many patients. If you were harmed by a recalled Stryker hip implant, a knowledgeable personal injury attorney can help you explore your legal options.
Best Intentions Still Resulted in a Flawed Design
When designing the Rejuvenate and ABG II devices, the Stryker Corporation tried to avoid the problems associated with metal-on-metal hip implants by forgoing the use of all-metal components, as well as the common single-piece stem and neck “monoblock” construction. Despite the fact that they're not constructed entirely of metal, Stryker device necks are made of cobalt and chromium, while the neck stems have a titanium coating. Though these components were supposed to be resistant to corrosion, the metals rubbed against each other at the joint, causing corrosion and fretting that released toxic metal shavings into the tissue surrounding the implant. Even though the Stryker Rejuvenate and ABG II Modular-Neck hip stems don't feature the traditional metal-on-metal design, they still cause many of the same side effects and complications associated with all-metal hip implants.
Side Effects and Complications
Most types of medical implants have the potential to cause side effects, but the fretting that occurs at the joint of the Stryker hip implants results in a higher-than-normal rate of failure. In addition to device failure, patients who received the Stryker Rejuvenate or ABG II implants may experience an adverse local tissue reaction, known as ALTR, that causes serious injury or requires surgery.
Other side effects and complications associated with the recalled Stryker implants include:
- Pain in the abdomen, groin, and implant area
- Tissue poisoning caused by metal ions and fragments (metallosis)
- Body-wide inflammation caused by the presence of metal in the blood stream
- Weakening or fractures of the bones surrounding the joint
- Hip instability
- Difficulty standing or walking
- Reduced mobility
- Dissolution of necrotic bone tissue (osteolysis)
- Muscle atrophy due to immobility
- Pseudotumor masses surrounding the joint
Revision surgery to place the implant and reconstructive surgery made necessary by weakened, fractured bone tissue are two of the most serious complications associated with Stryker hip implants. These surgeries are not only costly, but also more invasive and painful than the initial surgery, requiring a longer period of recovery and rehabilitation. Also, having to go under the knife again puts patients at risk of surgical complications, such as infection.
Were You Harmed by Stryker Hip Implants?
If you or someone you love experienced side effects or complications from a faulty Stryker hip implant, you may be entitled to compensation for your physical injuries, as well as for pain and suffering. Contact the skilled personal injury attorneys with McGartland Law Firm to discuss your legal options. Call our office at 866-957-5141 or fill out our online contact form to schedule a free, no-obligation initial consultation. We accept personal injury cases from all across the nation and don't get paid until you receive a settlement.