Why Are People Filing Stryker ABG II & Rejuvenate Hip Replacement Lawsuits?
Like many other hip replacement device manufacturers, Stryker has faced litigation regarding damages and complications caused by metal-on-metal (MoM) hip replacement devices. The ﬁrst federal Stryker hip lawsuits were ﬁled in August of 2012 for injuries caused by the Rejuvenate and ABG II devices. Thousands have since been ﬁled in federal, state, and local courts around the U.S. Because the entire device is not made of metal components, Stryker claims their systems are not actual MoM devices. However, the metal-coated parts coming in contact with each other result in the same complications as complete MoM devices.
Research has shown that the wear occurring from metal-on-metal devices releases metal ions in the body leading to metallosis and other severe bodily damage. In addition, patients have accused Stryker of knowing about the risks associated with metal-on-metal devices for years without informing patients or healthcare providers of the risks.
Stryker is facing litigation related to the increased need for revision surgery for multiple hip replacement products.
Plaintiffs ﬁling lawsuits against Stryker may have experienced:
- Severe pain and inflammation
- Loss of mobility
- Bone loss or fracture
- Systemic inflammation due to metal poisoning
- Hip dislocation
In most cases, patients who suffered early device failure were forced to undergo revision surgery and may have required multiple reconstructions. Unfortunately, each additional surgery poses an additional risk of pain, infection, and an extended recovery time.
Which Stryker Hip Replacement Systems Have a High Failure Rate?
Although several other devices are currently facing litigation and recall, the three most significant failure rates for Stryker devices are the following:
- Rejuvenate Modular Neck-stem
- ABG II Modular Neck-stem
- LFIT V40 Femoral Head
These Stryker hip devices were approved by the US Food & Drug Administration (FDA) under the 510(k) Premarket Notiﬁcation Process. This process permitted a fast-track exemption allowing manufacturers to avoid costly clinical trials by claiming the devices are similar to others already approved for use. Consequently, the Stryker devices did not undergo human implantation testing before being released. By the time post-market adverse event reports began piling up, thousands of patients had already been injured.
What Are Signs of Malfunctioning Hip Replacement Products?
While some hip replacement failures occur without negligence or fault. Some are caused due to a malfunction in the replacement products used during the surgery.
Symptoms you may experience due to a defective replacement product include:
- continued joint pain
- damaged bone tissue, medically termed osteolysis
- metal debris accumulation in the area around the product, or metallosis
- development of pseudotumors, which are soft tissue masses occurring near the artificial parts
- hip dislocation
What Types of Treatment Are Available for Malfunctioning Hip Replacement Products?
Secondary surgery is required if hip replacement fails due to natural causes or defective products. This surgery is called revision surgery. If a revision is necessary due to malfunctioning replacement products, those products will need to be replaced with working artificial parts. In addition, symptoms such as metallosis, osteolysis, and pseudotumors will need to be treated in addition to replacing defective products.
Have the Defective Stryker ABG II & Rejuvenate Hip Replacement Systems Been Recalled?
Since 2011 Stryker has initiated hundreds of recalls with the FDA. As a large multinational corporation providing a broad range of products for multiple medical disciplines, many of these recalls are unrelated to their hip replacement products. However, the Stryker line of hip implant devices has a troubled history. As a result, the company has been forced to issue recalls of its devices on multiple occasions. The three Stryker hip replacement products with the most extensive recalls have been the ABG II, Rejuvenate, and LFIT V40 Femoral Head.
These recalls focus primarily on the failure rate of the replacement products due to metal-on-metal product design. Due to the high failure rate of these systems, multiple individual lawsuits and three mass litigation lawsuits have been filed.
The company has recalled nearly 100,000 hip replacement devices since 2011.
Why Were the ABG II and Rejuvenate Systems Recalled?
The Stryker Rejuvenate modular-neck stem for hip replacement surgery was approved by the U.S. Food and Drug Administration (FDA) in June 2008. The Stryker ABG-II modular-neck stem device was approved in November 2009. Both products were marketed for younger patients and advertised as high-performance devices intended to be more durable and longer-lasting.
The devices were designed to model the biomechanics and anatomy of the human hip and to provide enhanced stability. Additionally, they were both engineered as modular units to make implantation easier for the physician who could choose components to best ﬁt a particular patient. The Rejuvenate system included 6 stems and 16 necks, while the ABG-II system had 8 right stems, 8 left stems, and 10 necks for various conﬁgurations.
The Rejuvenate and ABG-II systems were not designed as strictly metal-on-metal implants, which had already been shown to be problematic but were supposed to resist metal fatigue and corrosion. Unfortunately, patients were still exposed to signiﬁcant risks caused by the devices’ construction of titanium, zirconium, molybdenum, and iron.
Both the Rejuvenate and ABG-II hip replacement devices were recalled in 2012 and discontinued within three years of introduction due to an abnormally high number of cases of metallosis and other side effects caused by corrosion and fritting of the modular-neck stems.
Why Was the LFIT V40 Femoral Head Recalled?
The Stryker LFIT V40 Femoral Head is a part of Stryker’s modular system, which is used in replacement surgery to replace the top portion of the large leg bone or femur. It was approved in 2001 and was designed to be used as a component with other Stryker components. The LFIT V40 device is constructed of the metals cobalt and chromium, which were believed to be exceedingly durable and relatively safe. In addition, the design was intended to match patient anatomy and mimic natural biomechanics to increase the range of motion and reduce dislocation events.
Unfortunately, in 2016, Stryker was forced to recall multiple model numbers of the LFIT V40 (CoCr) Femoral Head devices due to a high risk of taper lock failure. Failure of the femoral head could lead to hip dislocation, unseating of the head from the leg bone, fracture of the hip or leg, increased metallic debris, and other complications. Therefore, in 2017, the LFIT recall was expanded to include additional devices from the same line.
How Many Stryker ABG II & Rejuvenate Hip Replacement Lawsuits Have Been Filed?
Stryker has faced thousands of lawsuits regarding their hip replacement products, particularly for the ABG II and Rejuvenate implants. Additionally, hundreds of lawsuits have been filed for the LFIT V40 Femoral Head.
Stryker’s Rejuvenate and ABG II hip lawsuit history began with the ﬁrst lawsuits being ﬁled in 2012 but was quickly followed by hundreds of additional cases. Federal lawsuits were consolidated into multi-district litigation (MDL) in the U.S. District Court for the District of Minnesota. More than 700 state suits were consolidated into New Jersey multi-county litigation (MCL). Numerous lawsuits were also ﬁled in other states and local courts, and according to regulatory ﬁlings, the company was forced to set aside $1.3 billion for settlements in 2013.
Stryker hip lawsuits have accused the company of developing a product with a faulty design and of failing to disclose information about the devices’ risks to the public and the medical community. Plaintiffs have said that the devices were inadequately tested and have resulted in numerous injuries from defects.
What Stryker ABG II & Rejuvenate Hip Replacement Lawsuit Settlements Have There Been?
In 2014 Stryker paid over $2 billion in settlements for the ABG II and Rejuvenate system lawsuits. The settlement stipulated a March 2017 deadline for filing suits. By 2017, Stryker had spent more than anticipated for the ABG II and Rejuvenate suits, with an average settlement of $600,000 for each failed implant.
Although most settlements have been paid, New Jersey ABG II lawsuits still need to be heard. Additionally, as of October 2022, there are still 81 lawsuits pending in Minnesota Federal Court as multidistrict litigation for these systems.
The LFIT V40 Femoral Head lawsuits were filed in Minnesota and New Jersey. The New Jersey suits were formed into an MCL. Although Stryker reached a confidential settlement regarding the LFIT V40 Femoral Head cases in 2018, there are still 581 lawsuits pending mass litigation in Minnesota.
What Stryker ABG II & Rejuvenate Hip Replacement Class Action Lawsuits Are There?
There are no current class action lawsuits against Stryker regarding their hip replacement devices. However, multi-district litigation (MDL) and multi-county litigation (MCL) suits have been created. This type of litigation occurs when lawsuits from different locations are consolidated and transferred so that one judge can hear all the cases simultaneously. This is typically done to speed up litigation when cases are more complex. The MDL and MCL lawsuits for the ABG II, Rejuvenate, and LFIT V40 have reached initial settlements. However, all still have cases pending.
Who Qualifies for a Stryker ABG II & Rejuvenate Hip Replacement Lawsuit?
Patients whose Stryker hip replacement devices were recalled or faulty may be eligible to file a lawsuit against Stryker Corporation to recover from the financial damages incurred. Lost wages, hospital bills, and other medical expenses are some of the damages that Stryker hip replacement patients may be entitled to receive. If you are still determining if the hip implant device used in your surgery is part of the recalled products, reach out to your doctor immediately. Do not wait for the hip implant to fail or malfunction.
How Do I Find a Stryker ABG II & Rejuvenate Hip Replacement Attorney?
If your Stryker hip replacement device has been recalled and you’ve learned from your doctor that the cause of your adverse side effects was due to defects in the device, you should contact a Stryker hip replacement lawyer. Law firms like Seeger Weiss specialize in litigation against large corporations like Stryker.