Ohio Medical Device Lawyer Investigating Stryker Recall Claims
In July, 2012, Stryker Corporation voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The initial press release from Stryker states the decision was based on “potential risks associated with fretting and corrosion at the modular neck junction.” Stryker’s decision to recall their implants not only halted global distribution and future operations, but recommended that surgeons consider the removal of Rejuvenate and ABG II modular-neck stems.
More recently, in September, 2016, the Australian Therapeutic Goods Administration warned in a hazard alert that the modular components used in Stryker’s Accolade hip replacements have higher-than-expected rates of failures. It has been identified that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have high incidences of taper lock failures.
Australian health officials have identified seven models using the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm, which may cause issues for patients. An entire line of Stryker’s products with similar specifications has also been included in the hazard alert. The affected Stryker femoral heads are used in the following models:
• Accolade TMZF
• Accolade 2
Joe Lyon has represented hundreds of individuals harmed by faulty medical device products nationwide. For questions related to the Stryker lawsuit call for a no cost consultation (800) 513-2403.
Patients uncertain which product they had implanted should consult their medical records — requesting the “peel stickers” or product ID stickers from the Hospital where the device was implanted.
Stryker advises patients with these particular hip replacement systems to schedule a follow-up evaluation with the surgeon who performed the procedure to discuss possible issues. Qualified medical professionals will evaluate how the hip systems are functioning and can recommend possible treatment. They may order diagnostic testing, including diagnostic imaging on your hip, including X-rays, MRIs, or Ultrasound.
It may be necessary to adjust current post-operative plans. Surgeons may recommend revision surgeries, which are procedures performed to remove the old implants and replace them with new, safer components. For many patients, hip revision surgery is the only way to resolve pain or reduce serious health risks.
In 2008, Stryker was approved to release the Rejuvenate and ABG II modular-neck hip replacement systems.
These devices were touted as being different than traditional replacement joints. The metal-on-metal hip replacements promised greater flexibility, more stability, less stress on the bone and a longer-lasting replacement joint.
Unfortunately, minimal pre-market testing was performed to determine if the hip replacement products functioned as intended or were safe for use. The products were brought to market under the FDA’s 510(k) clearance process, which allowed for Stryker’s devices to be on a “fast track,” and approved based on the similarity to already existing devices, and did not require extensive testing to ensure safety.
The FDA has issued a statement, which warns hip implants could result in the following adverse effects:
• Bone Necrosis
• Joint dislocation
• Hip Implant Loosening or Fracture
Since 2011, reports of complications specifically with the Rejuvenate and ABG II have been increasingly common. Recipients of the devices complain of:
• Problems walking
• Significant pain
• Loosening of the hip implant
• Failure of the replacement joint
In addition, metal particles from implants may cause certain adverse reaction. A 2012 study published in the British Medical Journal warned that the metal-on-metal components of hip replacements could rub against each other and result in metal particles released into the surrounding tissue and blood stream. The particles could cause metal alkalosis (metallosis). It was not until after the release of this study that the Stryker recall of the Rejuvenate and ABG II systems occurred , citing the need to study the risks of their own products.
The FDA reports problems may include:
• General hypersensitivity reaction (skin rash)
• Neurological changes including sensory changes (auditory, or visual impairments)
• Psychological status change (including depression)
• Renal function impairment
• Thyroid dysfunction (including fatigue and weight gain)
More than 20,000 Rejuvenate and ABG II implants were sold before a Stryker recall was issued in July 2012, when it was determined that the modular neck stem components pose a substantial risk of fretting, corroding, and ultimately failing. Stryker has settled thousands of cases, however, problems continue to surface. Patients are encouraged to seek possible medical and legal representation.
If you or a loved one suffered an injury due to a faulty hip implant and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions