The typical hip implant system is a one-piece neck and stem construction known as a monoblock. Both Stryker’s Rejuvenate and ABG II products were designed as a system or series of different stems and necks that could be mounted together to more closely mimic a patient’s particular anatomy and physiology.
The Stryker Rejuvenate modular-neck stem was approved by the FDA in June of 2008. The hip was engineered to more closely model the biomechanics and anatomy of the human hip and provide enhanced stability. It was also designed to make implantation easier for the physician due to its “flexible system.”
The Stryker ABG II modular-neck stem device was approved in November of 2009. Both new products were marketed toward younger patients and advertised as “high performance.” They were supposed to resist metal fatigue, corrosion and theoretically last longer.
Unfortunately, since their neck components are made of chromium and cobalt, and the stems are coated with titanium, they can shed metallic debris into the body when they wear against each other, leading to further complications.
In 2012 Stryker Corporation issued a voluntary recall for both the Rejuvenate Modular and ABG II Modular-Neck Hip Stems. The company stopped all global sales and production of these products and is facing an ever-increasing number of lawsuits filed by patients who received the recalled hips.
In February 2012, three months prior to the hip recall, Stryker issued an “Urgent Field Safety Notice” to implant surgeons and hospital risk managers indicating the potential health hazards associated with the two products. The side effects stated include corrosion, fretting (a condition where minute shards of metallic components leach into a patient’s tissues, bones and/or bloodstream), and an increased rate of Adverse Local Tissue Reaction (ALTR) resulting in inflammation in and around the implant.
In April the same year, a second “Urgent Field Safety Notice” was issued by the company to surgeons and hospitals. It stated “excessive metal debris and/or ion generation” caused by “fretting and/or corrosion at or about the modular neck junction” that “may lead to increased metal ion generation in the surrounding joint space.”
Treatment and Trauma
The treatment required to address a failed Rejuvenate or ABG II hip is often a complicated revision surgery. It is a sophisticated procedure in which the entire femoral stem is removed and replaced with another, larger metal stem. Because the stem is inserted down the center of the femur bone, removal is quite traumatic and frequently results in fractures to the femur itself which then has to be repaired with more metal hardware. The end result is a complicated and prolonged recovery process with a high potential for permanent loss of hip function.
Hip Replacement Complications
- Blood toxicity from metal debris
- Malalignment and loosening of components
- Metallosis (corrosion and fretting)
- Tissue death in surrounding areas (Necrosis)
- Bone loss (Osteolysis)
- Pseudotumors (formation of “false” tumors, large collections of solid or semi-solid mass around the implant causing inflammation or pain and restricted movement)
- Revision surgery required due to severe pain and local reaction (considerably longer recovery time than the initial surgery)
- Additional surgery (weakening of bone tissue resulting in multiple fractures requiring reconstruction of the femur or a portion of the pelvic girdle)
LFIT V40 Femoral Head Recall
In September of 2016 health authorities in Australia issued an alert highlighting the risk of possible injuries relating to the Stryker LFIT V40 femoral head hip implant component. The alert cited a number of dangers including the elevated risk of component failure resulting injuries.
Less than a month before in August 2016 Stryker Orthopedics issued a recall on the LFIT V40 line of femoral heads. The recall was specific to any LFIT V40 components produced prior to 2011. These femoral heads were commonly used in conjunction with the Accolade stem and continue to show a high rate of failure. These failures have been associated with a variety of injuries including; pain, joint instability, loss of mobility, localized inflammation, dislocation, local tissue reaction, possible broken bones in proximity to the component and even leg length discrepancy. The failure of the LFIT V40 femoral head can also require patients to undergo painful, complicated revision surgery.
LEARN MORE FROM THE FDA: Class 2 Device Recall Stryker LFIT Anatomic V40 Femoral Head
Numerous Stryker lawsuits allege that Stryker was negligent in failing to warn the public about the high rate of failure. They also accuse the company of making fraudulent claims, stating that the titanium and cobalt chrome neck and stem in the Rejuvenate and ABG II were resistant to fretting and corroding. That has proven untrue.
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Don’t suffer alone. We can help. If you or someone you know had a Stryker Rejuvenate or Stryker ABG II Hip Replacement, call us today for a free consultation and review of your legal options. We take the Stryker hip replacement recall seriously. You may be entitled to compensation for medical expenses, loss of function or pain and suffering. Call Harding Mazzotti, LLP to speak with an experienced Stryker hip lawyer 24/7 at 1800LAW1010 (1.800.529.1010).