Hip replacement surgeries are intended to relieve chronic pain and increase range of movement by fixing or replacing damaged bone or cartilage in the hip joint. Originally hip implants were made of ceramic or a hard plastic. These devices had a large degree of success and are still used as replacements. Metal-on-metal hip implants emerged in the mid-1990s as the next generation of hip replacement technology. Indeed, thousands of individuals have led happier lives with reduced pain and suffering due to the work of these medical device companies. Unfortunately, thousands of other individuals have had their conditions made worse by the technology that was designed to fix their problems, which has led to dozens of recalls on numerous models of hip implant and billions of dollars in settlement claims on behalf of patients.
Joe Lyon is a highly rated Ohio attorney with a broad range of experience on medical device liability, product liability, and class action claims. For a free consultation on a faulty hip implant case, please call (800) 513-2403 to speak with Mr. Lyon.
Hip implants are categorized under the FDA 510K approval process, which is significantly less rigorous than other FDA approval processes. The 510K process allows companies to submit new products without submitting safety and efficacy testing data as long as they can prove that their product is significantly similar to a product already on the market. This system saves medical device companies money and get products to market more quickly, which has made it the predominant system for medical device approvals.
Unfortunately, once a product is on the market it often takes numerous cases of device failure or severe side effects for companies to address the issues or recall their product. This is certainly the case for metal-on-metal hip implants. Traditional hip implants had relatively low failure rates, often between 3%-5%. By comparison, some of the more notorious metal-on-metal implants, like the DePuy ASR fail in up to 49% of patients after 6 years according to the British Hip Society.
The British Medical Journal published an article in 2012 that explained that the metal-on-metal failure epidemic was not a small or unforeseen issue. They blamed the process for approving medical devices as “[unable] to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally”
However, due to the consistency and severity of complaints to the FDA regarding metal-on-metal implants, the FDA required five producers of all-metal implants to conduct intensive long-term studies on the effects of their implants. The U.S. does not maintain an orthopedic registry that follows patient outcomes, unlike countries such as Britain and Australia. The lack of available data on outcomes puts responsibility on patients and lawyers, to litigate against medical device companies in order to force recalls.
Companies who have issued recalls include:
• Smith & Nephew
The following is an incomplete list of recalled hip replacement devices.
• Biomet M2a Magnum
• DePuy ASR XL
• DePuy ASR XL Acetabular
• Smith & Nephew Birmingham System (BHR)
• Smith & Nephew R3 System
• Stryker ABG II
• Stryker Accolade 2
• Stryker Accolade TMZF
• Stryker Citation
• Stryker LFIT V40
• Stryker Meridian
• Stryker Rejuvenate
• Stryker Trident Hemispherical Cup System
• Wright Conserve Plus
• Wright Profemur Z Hip Stem
• Zimmer Durom
The U.S Food and Drug Administration (FDA) urges patients who receive metal-on-metal hip implants to pay close attention to changes in their general health including new or worsening symptoms outside their hip. The signs of a failing hip replacement are potentially dangerous if left untreated. Some of the warning signs include:
• Severe joint pain
• Bone fracture around the implant
• Inability to walk
• Implant failure, dislocation or loosening
• Dead tissue/bones around the implant
• Formation of cysts or pseudo-tumors
• Allergic reaction to metallic debris
• Cobalt or chromium poisoning
• Nerve damage
In addition, metal particles from implants may cause certain adverse reaction. A 2012 study published in the British Medical Journal warned that the metal-on-metal components of hip replacements could rub against each other and result in metal particles released into the surrounding tissue and blood stream. The particles could cause metal alkalosis (metallosis). It was not until after the release of this study that the Stryker recall of the Rejuvenate and ABG II systems occurred, citing the need to study the risks of their own products.
More than 20,000 Rejuvenate and ABG II implants were sold before a Stryker recall was issued in July 2012, when it was determined that the modular neck stem components pose a substantial risk of fretting, corroding, and ultimately failing. Stryker has settled thousands of cases, however, problems continue to surface. Patients are encouraged to seek possible medical and legal representation.
In response to numerous complaints from orthopedic surgeons and patients, as well as new clinical data showing an increased rate of revision surgery associated with DePuy ASR XL Acetabular hip implant systems, DePuy Orthopedics voluntarily recalled all of its ASR XL Acetabular hip replacement devices, as announced by the company in August 2010. According to Dr. Joshua J. Jacobs from the Rush University Medical Center, “Most major medical centers have seen issues with this device. [The Depuy recall] does not come as a surprise.” Since the Depuy ASR recall, other metal on metal hip implants by a variety of manufactures have been implicated in lawsuits due to the defective design, failure to warn, and breach of warranties. Patients at the highest risk are female recipients and those who received ASR head sizes below 50 mm in diameter.
Johnson & Johnson, the parent company for DePuy, officially announced a $4B settlement in the ASR case, which amounted to an average plaintiff settlement of $300,000.
Smith & Nephew is a British multinational corporation that develops metal-on-metal hip implants, and other medical equipment. The company manufactures and sells a variety of hip replacement and resurfacing products, some of which have been recalled, injured patients and stimulated lawsuits in the U.S.
In 2012, the U.S. Securities and Exchange Commission (SEC) investigated Smith & Nephew for allegedly paying doctors employed by foreign governments to use the company’s equipment instead of competitors’ products. In a settlement, Smith & Nephew paid $22 million in fines.
In 2012, a New York woman filed a product liability lawsuit against Smith & Nephew. Her attorneys claimed she had suffered instability consistent with anterior dislocation and severe pain, requiring emergency care.
In September, 2016, the Australian Therapeutic Goods Administration warned in a hazard alert that the modular components used in Stryker’s Accolade hip replacements have higher-than-expected rates of failures. It has been identified that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have high incidences of taper lock failures.
Australian health officials have identified seven models using the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm, which may cause issues for patients. An entire line of Stryker’s products with similar specifications has also been included in the hazard alert. The affected Stryker femoral heads are used in the following models:
• Accolade TMZF
• Accolade 2
If you or a loved one suffered from a faulty hip implant, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.