Alaska Plaintiff Alleges Elevated Levels of Metal Ions
Stryker is facing a new hip replacement lawsuit alleging injuries from the Accolade TMZF femoral stem with the LFIT V40 head. The plaintiffs allege that the hip implants caused metal-on-metal hip complications, including fretting and corrosion from the metal surfaces rubbing against one another. The LFIT V40 femoral head was recalled last year due to a risk of taper lock failure.
Parker Waichman LLP personal injury law firm notes that metal-on-metal hip implants have come under 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 pursuing a case.
The lawsuit was filed in the U.S. District Court for the District of Alaska. According to the complaint, the plaintiffs allege that the LFIT V40 is defective and prone to premature loosening, disassociation, fretting and corrosion. These complications prompt early hip implant failure, the suit alleges. The device in question is a type of metal-on-metal hip implant; these devices have become controversial in light of high-profile recalls, injury lawsuits and safety concerns.
Various Stryker hip replacement products use the LFIT Anatomic CoCr Femoral Heads, including the Accolade TMZF, Accolade 2, the Meridian, and the Citation.
The plaintiff had the Stryker hip replacement implanted in March 2008. According to the lawsuit, several adverse events occurred a few years later. Doctors found that the plaintiff had elevated levels of cobalt in his blood; elevated metal ion levels are a sign of metal-on-metal hip implant failure because the metal surfaces release debris when they grind against one another.
Additionally, an MRI showed that the plaintiff had a large soft tissue mass.
A potential adverse event with metal-on-metal hip implants is a pseudotumor, or fluid-filled pockets. According to the complaint, physicians believed that these complications were caused by corrosion of the metal-on-metal hip implant between the LFIT V40 head and the Accolade TMZF stem. To address these issues, the surgeon advised a revision surgery. Revision surgeries are performed when the hip implant fails due to complications; the failed device is removed and replaced.
According to the lawsuit, a revision surgery was performed in January 2015. The complaint states that surgeons discovered other problems during the revision surgery, including chronic inflammation at the hip joint, tissue damage and corrosion. Specifically, doctors found that the metal surfaces at the head-neck junction had corroded, leading to “trunnionosis”. Studies suggest that this condition contributes to pseudotumors and other complications related to metal-on-metal hip implants, the suit states.
LFIT V40 Femoral Heads Recalled
Parker Waichman notes that the LFIT V40 femoral heads were recalled in 2016 due to reports of taper lock failure. The taper lock is the portion joining the femoral head to the femoral neck. Health regulators in both Canada and Australia warned of the issue.
In August 2016, a notification posted on Health Canada’s website stated, “Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011,”
In Australia, the taper lock failure prompted regulators to issue a “hazard alert”. The Therapeutic Goods Administration of the Australian Government Department of Health issued the notification in September 2016 noting “that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have a higher than expected incidence of taper lock failures. The taper lock is the part of the implant that connects the femoral head to the femoral neck.”
According to the alert, adverse events that may occur in patients with taper lock failure include:
• loss of mobility
• adverse local tissue reaction
• joint instability
• broken bones around the components
• leg length discrepancy
• need for revision surgery
If taper lock failure occurs with the Stryker LFIT V40 femoral head, patients may exhibit dissociation of the femoral head from the hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of movement, insufficient soft tissue tension, noise from the implant, loss of implant, bone fixation strength, increased wear debris and implant construct with a shortened neck length.
Stryker Metal-on-metal Hip Implant Lawsuits
Stryker has faced litigation involving metal-on-metal hip implants in the past. In June 2012, the company recalled its Rejuvenate and ABG II hip replacements. The recall was issued because these devices are associated with a risk of “fretting and corrosion” at the modular-neck junction. This can cause adverse local tissue reaction (ALTR), pain and swelling near the hip joint.
Stryker faced a flood of lawsuits following the recall, leading to a $1.4 billion settlement in November 2014. The settlement was recently expanded to include plaintiffs who underwent revision surgery to replace their failed hip implant before Dec. 19, 2016.
Metal-on-metal hip implants have been the subject of thousands of lawsuits. Concerns began after DePuy Orthopaedics issued a worldwide recall for its ASR metal-on-metal hip implants in 2010, citing a high rate of failure.
To review concerns surrounding metal-on-metal hip implants, the U.S. Food and Drug Administration (FDA) convened an expert panel in 2012. The Orthopaedic and Rehabilitation Devices Advisory Panel concluded that metal-on-metal hip implants are associated with “unique risks.”
According to the FDA, “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD).’”
Legal Help for Stryker Metal-on-Metal Hip Implant Recipients
Parker Waichman has years of experience representing clients in numerous metal-on-metal hip implant lawsuits. If you or someone you know was implanted with a Stryker metal-on-metal hip implant such as the Stryker ABG II or the LFIT, you may have valuable legal rights. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).