Stryker Rejuvenate and ABG II
In 2008, Stryker released the Stryker Rejuvenate and ABG II hip devices onto the U.S. Market. These products make up the femoral components of a total hip replacement product, specifically, the femoral stem pieces. The Rejuvenate and ABG II products are considered modular, rather than monolithic. This means that instead of there being one rod to insert into the hip femur, there are two pieces, the neck and stem, that fit together.
Stryker LFIT COCR V40 Head
The Stryker LFIT COCR V40 femoral head product has been on the U.S. market since the early 2000s. The metal V40 head is placed onto a femoral neck in a total hip replacement procedure. When a metal femoral neck is used, which is primarily always the case, pairing a metal head with a metal neck creates a metal-on-metal interface. The Stryker V40 head is often paired with the Stryker Accolade neck, which is made of metal.
Case Quick Facts
Stryker Rejuvenate and ABGII
Stryker touted its Rejuvenate and ABG II modular products as being beneficial over monolithic femoral components because they allow for specific adjustment for the size and offsets of each patient’s body makeup. However, the neck-stem pieces, unlike the monolithic pieces, have the capacity for metal-on-metal wear at the neck-stem interface.
Specifically, it was found that micro-movement would occur between the neck and stem pieces, causing fretting and corrosion of the neck-stem tapers. This would cause dangerous metal ion release into the body, metallosis, pseudotumor, and the need for very invasive revision surgeries.
The Stryker Rejuvenate/ABG II products are made of a material Stryker designed called TMZF. This is a titanium metal combination that allows for flexibility in the material. While Stryker touted this flexible material as beneficial for patient movement, the flexibility also lent to increased micro-movement resulting in fretting and corrosion.
In July 2012, Stryker recalled its Rejuvenate and ABG II modular necks from the U.S. market.
Stryker LFIT V40 Femoral Heads
In August 2016, Stryker initiated a voluntary recall of several of its LFIT COCR V40 femoral heads, claiming reports of metallosis and corrosion at the neck-head interface. The V40 head is often paired with the Stryker Accolade neck. Some versions of the Accolade neck are made of the same material, TMZF, of which the Stryker Rejuvenate femoral components were comprised. Patients are reporting similar complaints as to those involved in the Rejuvenate cases, including, metallosis, pseudotumors, pain, and need for revision surgery. Additionally, some of these V40 devices have been found to disassociate from the femoral neck causing severe damage.
In May 2018, Stryker warned that certain LFIT V40 femoral heads, manufactured between 2001 and May 2011, were linked to a high number of complaints involving femoral head/hip stem dissociation. This can lead to serious complications, including loss of mobility, adverse local tissue reaction, dislocation, pain due to implant loosening, leg length discrepancy, and need for revision surgery. Stryker did not have healthcare providers return the affected LFIT V40 femoral heads and has advised surgeons to continue normal follow-up with patients that receive the implant.
The main concern with the Stryker ABG II, Rejuvenate, and B40 hips is the fretting and corrosion of the stem and neck joint, which can cause elevated levels of chromium and cobalt in the bloodstream (metallosis). This can lead to the following complications:
- Pain/limited mobility
- Tissue inflammation/swelling
- Formation of tumors or pseudo-tumors
- Bone loss or dissolution
- Tissue death (necrosis)
- Adverse Local Tissue Reaction
- Elevated metal levels or metallosis
- Need for revision surgery
In these cases, Stryker is the defendant, as they developed and created the Rejuvenate, ABG II and V40 hip replacement devices.
GoldenbergLaw Can Help
A multidistrict litigation was created in the District of Minnesota as well as a consolidated action in New Jersey State Court to address the recalled Stryker Rejuvenate and ABG II hip products. In 2014, the first Stryker rejuvenate/ABG II global settlement was announced. In 2016, a second global settlement was announced to include individuals who experienced device failure after the deadlines of the first settlement. There are currently still many people being injured by this product. The litigation against Stryker is ongoing.
Shortly after Stryker recalled some of its V40 heads, a multidistrict litigation was created in the District of Massachusetts to address the failure of the Stryker V40 hip product. This litigation is currently ongoing and GoldenbergLaw is accepting cases.
Additional Defective Hip Resources
Our Stryker hip replacement lawyers have been handling defective hip cases for over 30 years. Regardless of the hip product that is causing you distress, we have the experience to make you feel confident that you are putting your case and information in the right hands. Learn more about the other defective hip cases we are working on.
If you find yourself needing a Stryker hip replacement lawyer, our experienced team would be happy to take a look at your case. Reach out today for a free consultation.
The 501(k) Approval Process
Stryker Rejuvenate and ABG II modular stems were approved in 2008 through the FDA’s 510(k) clearance track, meaning Stryker was able to prove that the devices were substantially equivalent to an existing device. This allows manufacturers to skip the in-depth testing that the FDA requires of new devices. The DePuy ASR, Pinnacle and many other metal-on-metal hips were approved through the same process.
The device that was compared to these products these products in the 510(k) approval process (“predicate device”) was Wright Medical’s Profemur stem, which has a similar “modular” stem design.
What is a Multidistrict Litigation?
A multidistrict litigation (MDL) is a consolidated action in federal court. It is important to make the distinction between an MDL and a class action litigation:
In class actions, one representative lawsuit is filed by one or more plaintiffs on behalf of many other claimants. Compensation is often divided equally. This is why class actions are generally inappropriate for claims involving injuries (such as hip device failures).
In a multidistrict litigation, individual cases are consolidated in one district of the United States and under one judge for pre-trial proceedings such as discovery and causation. This includes things like document review, depositions, and development of expert witness reports. In the end, each claim remains individual and is awarded compensation based on its individual damages and merits.
FDA Guidelines for Chromium and Cobalt Testing
Soft Tissue Imaging
The first method discussed in the FDA report is soft tissue imaging. Depending on the individual circumstances, the FDA recommends one of the following:
- Magnetic Resonance Imaging (MRI) with metal artifact reduction (MAR)
This technology offers the best visualization of soft tissue surrounding a metal-on-metal hip implant and uses non-ionizaing radiation. Panel members at the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel Meeting recommended this method over others that were discussed. However, this method is contraindicated for some patients with implants.
- Computed Tomography Scan (CT) Scan
CT scans offer the best visualization of implant positioning and bony tissue. However, they use ionizing radiation and provide lower soft tissue visualization. Image artifacts from the implant may distort the images.
Ultrasound allows soft tissue visualization without metal artifacts and uses non-ionizing radiation. However, it provides a lower resolution soft-tissue image and has a limited depth penetration.
These tests will show the tissue surrounding the implant and any distortions in the imaging will alert your doctor to metal artifacts (particles of metal) around the implant. Your doctor can determine which test is most appropriate for your situation. Keep in mind that his or her decision may also be based on what types of tests insurance will cover.
Chromium and Cobalt Ion Tests
As you likely know, elevated metal ion levels (e.g. chromium and/or cobalt) are a concern for anyone who has a metal-on-metal hip. Ions are not visible on the imaging tests listed above, so a blood sample must be tested in order to detect them.
The FDA says that anyone who develops symptoms should be tested. However, a recent study provided evidence that blood metal ion tests can be used to measure the risk of early joint failure. The study also suggested that elevated metal ion levels, regardless of symptoms, warrant concern. This means that even symptomless patients who have undergone metal-on-metal hip replacement surgery could still have increased ion levels that predict implant failure. For this reason, we recommend that metal-on-metal hip recipients undergo chromium and cobalt testing regardless.
The FDA specifies blood test methods they believe will produce the most accurate results. These tests are rarely done in your doctor’s office; he or she will most likely send you to a lab to have them done. The FDA also specifies the criteria a lab should meet to generate the most accurate results. Many doctors have already been using labs that meet these criteria, but some may be using testing labs that are outside of the FDA’s new guidelines. Before you get tested at a lab, we recommend checking with your doctor to make sure the lab meets the FDA’s criteria for accurate chromium and cobalt testing.