Smith & Nephew Tandem Bipolar Hip System Recalled Over Assembly Issues
Litigation is mounting against device maker Smith & Nephew of Memphis, Tennessee over its Tandem Bipolar Hip System. They system may detach after surgery.
Smith & Nephew issued a recall August 2016, advising medical customers to return any stock product. The U.S. Food and Drug Administration (FDA) followed up with a Class 2 device recall notification on November 3, 2016, because “some Bipolar shells were manufactured with an out-of-specification retainer groove.” A Class 2 recall designation means that the recall involves a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote.
The Australian Department of Health also issued a hazard alert on September 12 advising patients and health professionals that the manufacturing defect, “could lead to three potential failures, including the device not assembling properly and the head being too tight and not moving freely. Both of these failures would be identified during preparation before the implantation surgery.” The agency added that, “The third potential failure is the device may appear to be assembled properly during the implantation surgery, but parts become detached at a later time. If the third failure occurs, it could result in adverse events and require revision surgery.” When preparing for surgery, the surgeon should hear a click once the device components are properly assembled. Should a surgeon implant an incorrectly assembled device, the device may detach, a defect that will likely occur in the weeks following surgery.
Revision surgeries are more complex, more expensive procedures that are riskier and require longer healing times and, as Consumers Union pointed out, involve longer hospital stays. Despite that revision surgeries are typically performed to remove a device maker’s faulty device, the costs are assumed, not by the device maker, but by consumers and insurers, such as Medicare.
The recalled Smith & Nephew device is a partial hip replacement meant to replace half of the hip joint (hemiarthroplasty) in which the femoral head or ball of the damaged hip is replaced. To date, 5,806 units were distributed nationwide and in 23 developed nations.
Signs of the hip failure include unexpected pain, limited mobility, and/or loss of range-of-motion.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation, including litigation involving metal-on-metal hip devices. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip replacement lawsuit.
Metal-on-Metal Hips Long Associated with Health Issues
Metal-on-metal hips were developed for greater durability and longevity and with the objective that the purportedly stronger parts would be far superior when compared to their more traditional counterparts that were constructed with plastic or ceramic elements. Research has tied metal-on-metal hip devices to adverse events that include tissue necrosis, pain at the implant site that may spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and pseudotumors (fluid collection/solid masses around the hip joint). The issue with these devices appears to be with the metal used in these implants, which were touted to last for at least two decades.
Plaintiffs allege that metal hip devices led to serious health complications due to their faulty design. These devices have come under scrutiny in light of high-profile recalls and litigation and reports of high failure rates. Numerous lawsuits have also been filed against different metal hip makers over the past few years, and those cases continue to proceed.
Metal-on-metal hip implants use all-metal surfaces. When the implant surfaces rub together, even during normal activities such as walking, the devices may release metal debris, leading to complications. When an implant fails due to complications, patients typically undergo a revision surgery to remove the device.
Concerns over metal-on-metal hips became highlighted when Johnson & Johnson’s orthopedic unit, DePuy Orthopaedics recalled the ASR Hip Resurfacing System and the ASR XL Acetabular System in 2010 over high failure rates. At the time of the recall, J&J reported the ASR failure rate was 12 percent in five years. Internal documents, however, revealed that 37 percent of the implants failed in 4.6 years. In Australia, the failure rate was 44 percent in seven years.
Stryker also issued a recall in June 2012 of its Rejuvenate Modular and ABG II Modular-Neck Hip Stems due to potential health risks, including corrosion and “fretting” of metallic particles into a patient’s body. In November 2014, Stryker agreed to pay $1.45 billion to settle lawsuits over these devices. Under this settlement, patients may be eligible to receive $300,000 if they had one hip device implanted and removed and up to $600,000 for patients with both hip implants removed. The base amounts may be adjusted after considering severity of injuries and if multiple surgeries were needed. The settlement also includes individuals who were injured but unable to undergo revision surgery due to medical issues.
Metal-on-metal hip implants, as a class, have long been the subject of safety concerns. The devices were approved using the FDA’s fast-tracked 510(k) route, which bypasses clinical testing. Now, studies reveal that metal hip replacements tend to fail more often than other implants.
Previously, the FDA issued a Safety Alert acknowledging the risks associated with metal hip devices and issued new guidelines for all-metal hip patients. The agency advised that people implanted with all-metal devices undergo physical exams, diagnostics imaging, and metal-ion testing, when necessary. In that same alert, the FDA also proposed new, stricter guidelines mandating manufacturers prove their devices are safe and effective through clinical testing, a method known as “premarket approval.”
SCENHIR, the European Union’s Scientific Committee on Emerging and Newly Identified Health Risks urged caution with metal-on-metal hip implants indicating that it found that use of the devices should be “carefully considered on a case-by-case basis, due to the potential adverse effects of released metal.” Metal hip implants are contraindicated in women of childbearing age and in women with small femoral head size. SCENHIR also advised annual follow-up for the lift of the joint in patients with large-head devices.
Filing a Metal-on-Metal Hip Implant Lawsuit
If you or someone you know suffered injuries related to the use of a metal-on-metal hip implant device, 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).