Cincinnati product liability lawyer reviewing why Hip Implant Defect injuries occur and Devices Fail on Patients
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.
For a free consultation on a hip implant defect case, please call (800) 513-2403 to speak with Mr. Lyon.
Hip Implant Defects & Device Failure
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”
Defective Metal-on-Metal Hip Injury
There are a number of risks associated with metal-on-metal hip implants. Patients have reported various problems years after their initial surgery. Progressive pain is common, as is the issue of metallosis. The BHR implant, for example, is made of cobalt and chromium, and the levels of these metals in the blood can become dangerously elevated.
Metal-on-metal resurfacing releases large amounts of very small particles and metal ions. The long-term biological consequences of the exposure to Co-Cr particles and ions remain largely unknown, but there may be a toxic reaction to an excess of metal debris or a hypersensitivity reaction to a normal amount of metal debris.
Other patients who receive metal-on-metal resurfacing present with various symptoms and soft-tissue masses or pseudo-tumors. It is estimated that approximately 1 percent of patients who have a metal-on-metal resurfacing develop a pseudo-tumor within five years.
Metal-on-Metal Hip Defects & Injury
Metal-on-metal hip implants were developed to be more durable than traditional implants. Hip resurfacing techniques were introduced in the 1970s with the aim of minimizing the risk of dislocation, but the method was discarded after showing a high rate of failure. Results have improved over the years, however, there are still a number of reports of serious complications with this type of implant.
In a recent lawsuit, a Texas jury ordered Johnson & Johnson, and its DePuy subsidiary, to pay about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants. Lawyers argued that the Pinnacle hips were defectively designed, and that the companies failed to warn the public about their risks.
Metal-On-Metal Hip Implant Defect Recalls
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:
• Biomet M2a Magnum
• DePuy ASR XL
• Depuy Pinnacle
• Smith & Nephew Birmingham System (BHR)
• Wright Hip Implants
• Stryker Accolade 2
• Stryker Citation
• Stryker LFIT V40
• Stryker Meridian
• Stryker ABG Rejuvenate
• Stryker Trident Hemispherical Cup System
• Zimmer M/L Stem Kinectiv Hip
Symptoms of a Failed Hip Replacement
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
Risk of Metallosis
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.
Stryker Recall Litigation
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.
DePuy ASR XL Litigation
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 Hip Recall
In 2015, Smith & Nephew issued a field safety notice which warned consumers of current risks associated with their metal-on-metal hip resurfacing products. Patients have reported serious problems that include infections, fractures, dislocations, metallosis, and pseudo-tumors in the hips.
The company started selling their hip implants in the United States in 2009, many of which were recalled within the next three years after experiencing a higher-than-normal rate of revision surgery.
In the 2012 recall, Smith & Nephew said the metal liner of the replacement hip was “not performing as well” as the company expected, and stated it may lead to premature failure and potential health issues. Smith & Nephew’s chief medical officer said the company was “not satisfied with the clinical results of this component.”
The decision to withdraw a component of its metal-on-metal artificial hip system, followed a high percentage of patient problems. Clinical results showed that 1.6 percent of patients with the system needed revision surgery each year, almost double the safety guideline set by Britain’s National Institute for Health and Clinical Excellence.
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 hip implant defect product liability lawsuit against Smith & Nephew. Her attorneys claimed she had suffered instability consistent with anterior dislocation and severe pain, requiring emergency care.
Current personal injury and product liability lawsuits and settlements can compensate victims implanted with defective Smith and Nephew, Zimmer Biomet and Stryker systems.
Contact a hip replacement failure lawyer if you have been implanted with a defective product. Smith & Nephew has said patients who experience symptoms including pseudo-tumors, tissue masses, fluid collections, pain and swelling, buildup of excessive metal particles or metal hypersensitivity, may require revision surgery.
Metal on Metal Hip Risks
If a patient is fitted with a Birmingham Hip Replacement (BHR) System, or metal liners for its R3 acetabular system, the patient is at a risk of needing revision surgery. Those at greater risk of requiring a revision surgery:
• Males aged 65 or greater
• Patients requiring an implant head size <48mm
Stryker 2016 Recall and Litigation
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 various models.
Legal Action & Hip Implant Defect Claims
It may surprise many to learn how easy the FDA approval process is for new medical devices. As long as the device is “similar” to one already on the market, the FDA does not require clinical trials for orthopedic implants. Perhaps that is why so many defective devices affect American consumers and are recalled each year.
Victims and hip replacement failure lawyer are holding medical device companies responsible for the products they sell to vulnerable patients. Any person who has received a defective hip implant, and is experiencing adverse reactions due to the product, may have a claim against the device manufacturer. Contact an experienced medical device attorney for legal assistance and action.
If you or a loved one has suffered from a hip implant defect, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding your hip implant defect lawsuit.