State-Based Stryker Lawsuits Consolidated in New Jersey
The New Jersey Supreme Court recently approved consolidation of all pending and future state-based hip replacement implant failure lawsuits brought against Stryker Corp. subsidiary, Howmedica Osteonics Corp.. within a multicounty legislation. The medical device products involved are the LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral heads. The case is In re: Stryker LFIT Anatomic CoCr V40 Femoral Heads Litigation, Case No. 624, in the Superior Court of the State of New Jersey, County of Bergen.
The LFIT V40 Femoral Head is a hip replacement component that was recalled in 2016 over reports of taper lock failure. The alleged hip replacement implant failure involves corrosion at the point in which the head and neck intersect. The corrosion may cause the femoral head to break apart from the stem neck. This device failure would require immediate revision surgery.
The fretting of tiny metallic particles from the metal alloys are believed to cause inflammation and infection of surrounding tissue. There is also the potential for the alloys to be absorbed by the bloodstream, causing toxic metallosis (metal poisoning). Metallosis is a serious condition that requires revision surgery, even if the hip implant that is performing well.
The Stryker LFIT CoCr V40 Femoral Head may be used with various Stryker hip replacement products such as the Accolade TMZF, Accolade 2 Femoral Stems, Meridian Demoral Stems, and Citation Femoral Stems.
Parker Waichman LLP, a nationwide personal injury law firm, notes that metal-on-metal hip implants have come under increasing scrutiny following recalls and thousands of lawsuits. The firm represents numerous clients in metal-on-metal hip implant lawsuits and continues to offer free legal consultations to individuals who have questions about filing a Stryker LFIT CoCr V40 Femoral Head lawsuit.
Some hip implant components are created from metal alloys and not more traditional materials such as ceramic. Metal-on-metal implants were thought to extend the life of traditional hip implants, expanding the market to a growing population base that is younger and more active and comprised of individuals who are looking for a stronger, longer lasting implant.
Metal-on-metal implants and other newer designs were permitted to enter the market with minimal testing through the U.S. Food and Drug Administration’s (FDA) 510(k) clearance protocol, have proven to be problematic.
Previously, Stryker recalled certain lots of its femoral heads. The components involved were manufactured prior to March 2011 and were recalled due to “higher than expected” complaints concerning failure of the femoral head to fully lock onto the stem at the stem-head taper junction, known as “taper lock failure.”
Stryker has also been sued over its metal-on-metal ABG II and Rejuvenate hip implant medical device products, which were recalled in 2012 over a a risk of “fretting and corrosion.” The company recently expanded its $1.4 billion settlement for these lawsuits to include plaintiffs who underwent revision surgery prior to December 19, 2016. As for the Stryker LFIT V40 femoral head device, a federal multidistrict litigation is pending, as well.
Stryker LFIT V40 Femoral Component Background
In a total hip replacement, there is typically a femoral component that replaces the femur (thigh bone). The femoral component is comprised of several different parts, including a stem inserted into the bone and a ball (head) that sits on top. The ball and stem are joined at the femoral neck. This is known as a taper lock system. The femoral ball connects to the acetabular component, a cup that replaces the hip socket, to copy the hip joint’s natural motion.
The Stryker LFIT V40 femoral head has raised safety concerns because patients have been experiencing failure at the taper lock portion. This causes the hip to become unstable and has led to other adverse medical complications. When an implant fails due to complications, patients typically undergo a revision surgery to remove the device.
The femoral head is a device component that rests on top of the femoral stem, which is placed into the thighbone. The head is then placed within the acetabular cup, which lines the hip socket. The device is manufactured with cobalt and chromium, which are the same metals that comprise many of the acetabular cups. When the two parts rub against one another during normal wear and tear, such as when walking, arising, and sitting, the components may shed small metal shards into and around the joint and surrounding tissue. This shedding leads to inflammation, swelling, the development of fluid pockets, metallosis (metal poisoning), and other health issues that progressively lead to hip loosening, hip replacement failure, and the need for revision surgery.
Various studies have shown that corrosion may also occur at the head-to-neck juncture of these types of hip implants. A 2016 study found that nine cases of total hip implant failure were associated with metal wear debris in this area of the implant. Patients also suffered from abnormal levels of cobalt and chromium blood levels, tissue damage, and hip implant failure. All of the patients went through revision surgery to repair the implant. Revision surgery typically involves removing and replacing the allegedly defective device, which is a more painful, costlier, riskier, and complex process than the original surgery and is also associated with longer recovery times and hospital stays as well as intense and longer physical therapy. In some cases, insurers do not cover revision surgeries.
The taper lock portion of the component that connects the femoral head to the femoral neck may weaken or completely break, which may lead to catastrophic hip implant failure. Patients may suffer from broken bones, dislocation, joint instability, loss of mobility, increased metallic debris and metallosis, and significant pain. Taper lock failure may also lead to dissociation of the femoral head from the hip stem, fractured hip stem trunnion, insufficient range of movement and soft tissue tension, noise emanating from the implant, loss of the implant, minimized bone fixation strength, increased wear debris, and implant construct with a shortened neck length.
Specifically, when the ball and socket joint of the metal device interact, nothing prevents metal ions from entering the patient’s bloodstream, which may ultimately lead to metallosis. This may impair the patient’s condition by potentially leading to infection, fretting, corrosion, tissue death, and pseudotumor formation. Patients must typically undergo revision surgery to explant the defective device and undergo implantation with a different device when this occurs.
Symptoms of taper lock failure may include adverse total tissue reaction, broken bones in the area of the component, dislocation, inflammation, joint instability, leg length discrepancy, loss of mobility, need for revision surgery, and pain. Signs of the hip failure include unexpected pain, limited mobility, and/or loss of range of motion.
Filing Defective Medical Device Lawsuit
If you or someone you know suffered injuries related to the use of defective medical device or device component, including metal-on-metal hip replacement and other hip devices, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).