Thousands of lawsuits have been filed against Biomet involving problems with the company’s M2a Magnum hip implant, alleging that defects in the implant’s design caused patients to suffer severe complications requiring risky revision surgery. Metal-on-metal hip implants, like Biomet’s M2a Magnum device, were designed to last longer and wear less than traditional plastic or ceramic joint replacements, but studies have shown that the metal-on-metal design of these medical devices poses a unique risk due to the toxic metal particles the implants can shed into patients’ bodies when the metal components rub against one another. If you or a loved one has suffered complications like metal ion poisoning (metallosis) or premature device failure involving the Biomet M2a Magnum hip implant, contact a knowledgeable defective hip implant attorney today. You may be entitled to financial compensation for your injuries and medical bills, which you can pursue by filing a product liability lawsuit against Zimmer Biomet.
One recipient of a Biomet artificial hip, Patricia Gill of New York, was implanted with an M2a Magnum device in 2005. In her product liability lawsuit, Gill alleged that friction between the metal components of the hip implant released metallic particles into her blood and the tissue surrounding the implant, causing her to suffer severe pain and inflammation. Gill eventually required revision surgery to replace the implant. Another woman implanted with an M2a Magnum hip implant, Christina Kirk of Ohio, received the implant when she underwent a total hip replacement in 2007. Kirk filed a lawsuit against Biomet in federal court in May 2013, claiming that she suffered debilitating injuries caused by the artificial hip’s metal components releasing metallic debris into her body. In 2012, all lawsuits filed in federal court over problems with Biomet’s M2a Magnum hip implant were centralized in an Indiana federal court as part of a multidistrict litigation (MDL), and in 2014, Biomet agreed to pay a total of $56 million to settle the majority of these lawsuits. As of August 2018, more than 400 lawsuits were still pending in federal court.
• Metallosis
• Pseudotumors
• Tissue death
• Bone loss
• Premature implant failure
• Severe pain and inflammation
• Device dislocation
• Implant loosening
• Optic nerve damage
• Need for revision surgery
• Bone and soft tissue damage
• Loss of mobility
• Permanent disability
• Local adverse tissue reactions
Metal-on-metal hip implants, like Biomet’s M2a Magnum device, were designed to last longer and wear less than traditional plastic or ceramic joint replacements, but studies have shown that the metal-on-metal design of these medical devices poses a unique risk due to the toxic metal particles the implants can shed into patients’ bodies when the metal components rub against one another.
The manufacturers of metal-on-metal hip implants like Biomet’s M2a Magnum device claimed that the implants would last longer and wear less than older models, marketing them as appropriate for patients with more active lifestyles who needed better mobility and increased range of motion. However, a growing body of research has shown that all-metal hip devices can fail earlier than expected and put patients at risk for complications like metal ion poisoning and device dislocation. What’s more, these problems may make it more difficult to perform revision surgery to replace failed hip implants, which makes the surgery riskier and exposes patients to additional injuries. In 2016, in response to growing concerns about the safety of all-metal joint replacement devices, the FDA put new regulations in place requiring manufacturers of metal-on-metal hip implants to subject their devices to a more strenuous premarket approval process. This new process required manufacturers to report any known risks to the FDA and document and report the safety and effectiveness of their devices. Although the FDA received hundreds of reports of metal ion poisoning and other serious complications from failed Biomet M2a Magnum hips, the devices were never recalled.
Plaintiffs in the Biomet hip implant litigation allege that:
• Biomet manufactured and sold a defective hip replacement
• The M2a Magnum hip implant was not properly tested before entering the market
• The company knew or should have known about the potential for the metal-on-metal hips to cause serious injuries
• Biomet failed to adequately warn patients and the medical community about the potential risk of hip implant complications
Biomet’s M2a Magnum hip implant was part of the manufacturing company’s M2a line of joint replacement devices first introduced in 1996. Like many other metal-on-metal hip implants, the M2a Magnum was approved via the FDA’s 510(k) fast-track approval program, which allows manufacturers to put new devices on the market without conducting safety testing, so long as the devices are “substantially equivalent” to products already on the market. The M2a Magnum device features a metal-on-metal design, meaning the artificial ball and socket forming the replacement joint are both made of metal, a design that was once believed to decrease dislocation rates and improve performance and range of motion in patients, but has since been found to be problematic. From 1999 to 2009, more than 110,000 M2a Magnum devices were implanted in patients.
