Metal on Metal Hip Replacements
Our Hip Replacement Attorney Explains Your Eligibility for a Lawsuit
Hip Replacement Attorney Explains Your Legal Rights Regarding MoM Hip Replacements
Metal-on-Metal (MoM) hip replacements have been the subject of extensive litigation over the past decade. Still, given the significant number of patients with arthritis, artificial hips are the only option for them to regain some level of function that allows them to live as normal of a life as possible.
MoM hip replacements have proven to be defective and dangerous for patients. The United States Food and Drug Administration (FDA) is well aware of the complications associated with the implantation of MoM hip replacement devices. Just over 10 years ago, in May 2011, the FDA issued what is known as a “522 order” to all five manufacturers of MoM total hip replacement medical devices.
A 522 order mandates that manufacturers of medical devices undergo post-market studies to determine the safety and efficacy of the product. Because of evidence showing high levels of metal ions in patients with MoM hip replacements, the FDA ordered manufacturers to surveil existing patients to measure levels of metal ions in patients.
According to the FDA, some studies indicate that excess heavy metal ions may cause neurologic and cardiac disorders. In addition to metallosis or metal blood poisoning, patients with MoM hip implants have experienced implant failure in the form of loosening, fracture, and disassociation. Many complications have resulted in the need for hip replacement revision procedures.
At Searcy Denney, each hip replacement attorney at our firm represents clients nationwide, advocating for the rights of injured clients who have suffered significant injuries following the implantation of MoM hip replacement devices. Contact our office to speak with a hip replacement attorney who can evaluate your situation and determine whether you have a viable legal claim.
An Overview of Hip Replacement Surgeries
For quite some time, joint replacement surgery has offered patients with painful hips, knees, and other major joints significant pain relief and increased mobility. Because hip replacement procedures are popular, the market has exploded over the past couple of decades, leading to tough competition among manufacturers.
A hip joint normally operates with a ball-shaped head at the top of the femur (the thigh bone) that fits into a cup-shaped cavity called the acetabulum (the socket) at the base of the hip bone. This ball-and-socket arrangement gives the hip its ability to rotate. When hip joints become arthritic and deteriorate, total hip replacement surgery or total hip resurfacing may be needed.
Total Hip Replacement Surgery
During a total hip replacement surgery, damaged portions of a patient’s hip joint are removed and replaced by artificial devices. The ball at the top of the femur is replaced with a prosthetic ball of metal or ceramic; the socket (acetabulum) is removed and replaced with an artificial cup made of metal, ceramic, or plastic, plus a stem to support the femoral head.
Total Hip Resurfacing
During a total hip resurfacing surgery, the head of the femur is trimmed and covered with a metal cap instead of being replaced. Damaged bone and cartilage in the acetabulum are then removed, and a metal shell is inserted.
Popular implants used in many hip surgeries are MoM implants, where both the ball and socket are comprised of metal. Unfortunately, such a configuration has proven to be disastrous for patients, as described below.
Our Hip Replacement Attorney Knows the Dangers and Injuries Associated with MoM Hip Implants
Tough competition has led to the design, manufacture, and sale of numerous MoM hip implants, providing physicians with various options from which to choose. Of the estimated 250,000 hip replacement procedures performed each year, approximately one-third of these procedures involve implantation of MoM hip implants, which are comprised of cobalt and chromium.
Any hip replacement attorney who has extensively litigated defective hip implant cases has discovered that once an MoM device is implanted, the two metal components (ball and socket) rub together when they do not correctly fit with one another. By rubbing together, small metal shavings (ions) are dispersed and enter a patient’s blood system.
Once in a patient’s blood system, the metal debris/ions can cause inflammatory reactions, tissue damage, and bone loss around the area of the ball and socket connection. According to information provided by the FDA for patients regarding MoM implants, metal ions released into the bloodstream can cause medical conditions that include, but may not be limited to, the following:
- Skin rash
- Neurological changes, such as auditory or visual impairment
- Change in psychological status, such as depression or cognitive impairment
- Impairment of renal function
- Thyroid dysfunction, such as neck discomfort, fatigue, weight gain, or feeling cold
Metal ions that enter the bloodstream can lead to metallosis, which is a buildup of metal that kills surrounding tissues (necrosis). Symptoms of metallosis include, but may not be limited to, the following:
- Pain around the joint
- Difficulty walking
- Swelling at the implant site
Additionally, metallosis can lead to osteolysis, in which a bone degenerates, causing an implanted device to become loose. If a device loosens, it must be removed and replaced through a second surgery known as a “revision.”
MoM hip implants are unique in that they cause a wide variety of injuries. Most mass tort litigations involving defective medical devices are linked to a very narrow set of injuries. With MoM hip implants, patients experience everything from pain to blood poisoning to neurological issues.
Because of the significant number of patients experiencing horrific injuries following the implantation of MoM hip devices, many MoM products have been recalled. However, despite massive recalls, some manufacturers of MoM hip implants still deny that their products can cause catastrophic injuries, which is contrary to the evidence of documented complications.
FDA Approval v. FDA Clearance – Understanding the Difference
When a drug or medical device enters the marketplace, the general thought is that the products must undergo extensive testing to determine that (1) the product is safe for its intended use and (2) the product works as intended. However, many people do not realize that medical devices typically enter the marketplace through FDA clearance, which is NOT the same as FDA approval.
With FDA approval, the FDA requires that a product undergo testing on humans before the drug or device can be approved for use. Such testing is often long-term and involves many participants. With FDA clearance, which is also known as “510(k) clearance,” a product does not need to go through the long standard approval process.
Instead, a manufacturer seeking 510(k) clearance must demonstrate that its product is substantially similar to a product already on the market. As such, no testing of the product is required to obtain clearance. Manufacturers seeking to introduce a new drug to the market must go through the standard approval process, but manufacturers of medical devices can seek entry to the market through the 510(k) process.
Medical device manufacturers are responsible for the safety and efficacy of their products and assume this risk when rushing a product to market through the clearance process, which is essentially a shortcut. The FDA clearance process has shed light on just how many defective and dangerous products have entered the market.
A Skilled Hip Replacement Attorney Can Help You Identify Defective Metal-on-Metal Hip Implants
Numerous MoM hip implants are the subject of litigation nationwide. Given the substantial number of MoM devices, a hip replacement attorney must be able to identify the type of implant placed in a patient. Some orthopedic surgeons will thoroughly discuss the type of implant being placed, which includes the name of the manufacturer and the model of implant being used.
Some surgeons are not as thorough and fail to inform patients of the brand and model of MoM hip implant being used. Hip replacement attorneys have identified a vast list of manufacturers and MoM hip implants, many of which have been recalled and are discussed in more detail below.
Stryker Orthopaedics Metal-on-Metal Hip Implant Recall
Stryker Orthopaedics manufactured two MoM hip implants that were recalled in 2012 – the ABG-II and Rejuvenate. Both models are modular-neck hip stem implants. Stryker’s recall of these implants was due to fretting and corrosion at the modular-neck junction of the implants. Fretting and corrosion may lead to significant pain and/or swelling of the hip as well as the release of metal debris/ions that enter a patient’s bloodstream.
Numerous adverse event reports alleged that metal toxicity required revision hip replacement surgery. Stryker ultimately issued a recall after the FDA received nearly 50 adverse event reports regarding metal toxicity.
DePuy Orthopaedics Metal-on-Metal Hip Implant Recall
DePuy Orthopaedics is one of many subsidiaries of Johnson & Johnson. DePuy is the entity that designs, manufactures, and distributes orthopedic medical devices, such as total knee replacements and total hip replacements. In 2010, DePuy issued a recall of its ASR XL Acetabular hip implants, given that many patients with this implant have required revision surgeries.
Johnson & Johnson acknowledged that approximately 13% of patients who were implanted with the ASR XL Acetabular hip implants had failures, which were caused by one or more of the following:
- Loosening of the implant parts
- Sensitivity to metal
Plaintiffs injured by DePuy’s recalled hip implants allege that the defective nature of the product, which made it difficult for surgeons to properly implant, was the cause of their severe and permanent injuries.
Zimmer Metal-on-Metal Hip Implant Recall
Zimmer manufactured the Durom Cup hip implant, which was introduced into the market in 2006. After being implanted into approximately 13,000 individuals, Zimmer recalled the Durom Cup, citing complications associated with the hip implant that necessitated revision surgeries for many patients.
Smith & Nephew Metal-on-Metal Hip Implant Recall
In 2012, Smith & Nephew issued a recall of the metal liner on the R3 Acetabular modular hip implant after patients reported injuries including, but not limited to, fractures, dislocation of the implant, infections, and metal poisoning. Because of these serious injuries, many patients underwent painful revision procedures. Patients with the R3 Acetabular implant underwent procedures between 2009 and 2012.
Additional Metal-on-Metal Hip Implant Manufacturers
In addition to the key manufacturers identified above, the following manufacturers may also be subject to litigation for designing, manufacturing, and distributing defective metal-on-metal hip implants:
- Wright Medical Technology, a company that manufactures the CONSERVE metal-on-metal hip implant and the Profemur Z Step hip implant; and
- Biomet, a company that manufactures the M2a Magnum hip implant, the Stanmore hip implant, and the Exceed ABT hip implant.
Identifying the manufacturer and model of an MoM hip implant is critical to evaluating a potential claim. To determine the proper manufacturer, and therefore, the appropriate defendant in a possible hip replacement product liability lawsuit, a hip replacement attorney must review a patient’s medical records in detail. Without such crucial information, a potential legal claim cannot move forward.
Who Qualifies to Receive Compensation for MoM Hip Implant Injuries?
To find out if a potential client qualifies to potentially receive compensation as part of a MoM hip implant lawsuit or settlement, a hip replacement attorney will consider the following:
- The manufacturer of the MoM hip implant
- The model of MoM hip implant at issue
- The date of a patient’s original implant surgery
- Identification of symptoms and injuries
- The date of onset of symptoms
- The date of diagnosis or documentation of complications associated with a MoM hip implant
- Whether the product at issue is subject to a recall
- Whether the patient has undergone a revision procedure
- The date in which the patient became aware that he or she may have a potential legal claim
- How a patient found out he or she may have a potential legal claim (i.e., whether the patient saw a commercial on television or saw an advertisement online, for example)
Dates are extremely important when evaluating potential legal claims. As such, injured patients should keep a timeline of their experience to help a hip replacement attorney have the necessary information to review the patient’s potential case thoroughly.
The Aftermath of Metal-on-Metal Hip Implant Injuries
No compensation can ever be enough to account for irreversible damage caused by defective MoM hip implants. However, compensation is the only way the justice system can help to make injured plaintiffs “whole” again. Compensation can cover the cost of medical treatment, which can reach hundreds of thousands if not millions of dollars over a patient’s life.
Compensation can also help to replace the lost income and the inability to earn a living in the future in cases where hip replacement injuries are significant enough to cause permanent disability. To obtain much-needed compensation, injured plaintiffs must act by filing a lawsuit against the manufacturer of the MoM hip implant that caused injuries.
As part of the lawsuit, a hip replacement attorney will allege on behalf of injured plaintiffs that MoM hip implant manufacturers were not only negligent in rushing dangerous products to market but also that the MoM hip implants suffer design and/or manufacturing defects. Moreover, a skilled hip replacement attorney will argue that MoM hip implant manufacturers failed to warn doctors and patients about known dangers and risks associated with the intended use of their products.
“Failure to warn” claims are common with defective medical device cases, and a failure to warn often leads to the allegation that MoM hip implant manufacturers should be liable for punitive damages. Such damages are intended to punish manufacturers for bad conduct.
An example of bad conduct is knowing that a product is extremely dangerous, taking measures to conceal such information, and allowing the defective product to continue being placed into unwitting patients.
Our Hip Replacement Attorney Offers a Warning to Patients
Anyone who has an MoM hip replacement should be alert for post-surgery symptoms that could indicate an adverse reaction to metal particles from the implanted device. Patients with any of the following symptoms should consult their orthopedic surgeon, who may recommend blood tests, joint aspiration (removing fluid from around the joint), or special imaging tests:
- Pain in the groin, hip, or leg;
- Swelling at or near the hip joint;
- A limp or difficulty walking;
- Chest pain;
- Shortness of breath;
- Numbness or weakness;
- Changes in vision or hearing;
- Feeling cold;
- Weight gain; and
- Change in urination habits.
The FDA advises physicians to look for the following symptoms, which could be indicative of a reaction to metal debris/ions in a patient’s system:
- Local nerve palsy;
- Palpable mass;
- Local swelling; and
- Joint dislocation or subluxation (partial dislocation).
When counseling patients who are considering total hip replacement implants, the FDA warns orthopedic surgeons NOT to implant metal-on-metal hip systems in:
- Patients with moderate to severe renal insufficiency;
- Patients with known sensitivity to metals such as cobalt, chromium, or nickel;
- Patients with suppressed immune systems;
- Patients currently receiving high doses of corticosteroids; and
- Women of childbearing age.
A Message from a Nationwide Hip Replacement Attorney
While a hip replacement attorney cannot give medical advice to prospective or existing clients, a hip replacement attorney can share what questions patients may consider asking their doctors. Examples of questions that patients may ask include the following:
- What type of hip implant is being used?
- Is this hip implant comprised of metal?
- Is the product substantially similar to a product that is the subject of a recall?
- Who is the manufacturer of the hip implant?
- What is the name of the model of implant being used?
- Are there alternatives to undergoing a hip replacement procedure?
Each patient’s situation will be different, so questions may differ based on one’s medical history and the need for hip replacement surgery.
Contact a Hip Replacement Attorney at Searcy Denney Today for a Free Case Evaluation
To find out if you qualify to receive compensation as part of a metal-on-metal hip implant lawsuit, contact an experienced and dedicated hip replacement attorney as soon as possible. Unfortunately, because of strict time limitations that vary by state, injured patients do not have much time to act.
By speaking with a hip replacement attorney at Searcy Denney, you will learn whether your metal-on-metal hip implant has been recalled and whether you meet the established criteria for potentially receiving compensation.
Speak with an experienced lawyer today by calling (800) 780-8607 or by completing a case inquiry form on our website.