Patients suffering from these complications may be eligible to work with a defective hip replacement attorney and file a lawsuit against the manufacturer.
The experienced hip replacement lawyers at Di Pietro Partners, PLLC have decades of experience in medical malpractice and mass tort claims. Our litigation team has a board certified physician on staff to assist in the evaluation of your case, ensuring a comprehensive understanding of the medical issues at hand.
If you or someone you know has experienced issues involving a defective hip implant, contact us for a free consultation today.
Metal Hip Replacement Recall
DePuy ASR™ XL Acetabular System: Recalled in 2010 due to a high failure rate.
Stryker Rejuvenate and ABG II Modular-Neck Hip Stems: Recalled in 2012 because of the potential for fretting and corrosion, leading to adverse tissue reactions.
Zimmer Durom Cup: Temporarily suspended sales in 2008 and later issued a recall because surgeons needed more information about the surgical technique for implanting the device.
Biomet M2a Magnum Hip System: Faced lawsuits due to problems with metal-on-metal components but wasn’t officially recalled. Patients reported issues similar to those seen in other metal-on-metal hip implants.
Smith & Nephew R3 Acetabular System Metal Liners: Recalled in 2012 due to a higher than expected revision surgery rate.
Wright Conserve Hip Device: Not recalled but subject to lawsuits over complications with its metal-on-metal design.
Exactech Connexion GXL Liners: Recalled in 2021 due to higher than expected wear rates leading to osteolysis and revision surgeries.
Hip Replacement Surgeries
Hip Resurfacing Surgery – Hip resurfacing is a surgical alternative to total hip replacement that is often considered for younger, more active patients. In this procedure, the damaged surface of the femoral head (the ball portion of the hip) is trimmed and capped with a smooth metal covering, while the hip socket is lined with a metal shell. This technique preserves more of the patient’s natural bone structure compared to a total hip replacement. Hip resurfacing may allow for a greater range of motion and higher activity levels post-surgery. However, it’s not suitable for all patients, such as those with significant bone loss or certain bone diseases.
Partial Hip Replacement Surgery – Also known as hemiarthroplasty, a partial hip replacement involves replacing only the femoral head, while the acetabulum (hip socket) remains untouched. This type of surgery is typically performed after hip fractures or in cases where only one component of the hip joint is damaged. Partial hip replacements are often considered for older, less active patients who may not put as much demand on the joint. The primary advantage is a potentially shorter recovery time and preservation of more natural bone, though the risk of future surgeries to replace the socket may increase.
Total Hip Replacement Surgery – Total hip replacement, or arthroplasty, involves removing and replacing both the femoral head and the acetabulum with artificial components. The new femoral head is usually made of metal or ceramic, while the socket can be lined with metal, polyethylene, or a combination of materials. Total hip replacement is a common and highly successful procedure designed to relieve pain and improve mobility in patients with severe hip damage from arthritis, fractures, or other conditions. It offers a long-term solution for those experiencing significant hip pain and functional limitations, with various implant materials and designs tailored to patient needs.
Hip Replacement Revision Surgery
Hip replacement revision surgery is a crucial procedure undertaken when issues arise with an existing hip implant, either due to wear and tear over time or complications related to the implant’s performance. This surgery aims to address and rectify any problems, ensuring the patient’s mobility and quality of life are restored. Reasons for revision surgery can vary, including the loosening of the implant within the bone, infection, dislocation, or the device’s mechanical failure.
Over time, even well-functioning implants may degrade or wear out, necessitating replacement. Additionally, in cases where the implant is found to be faulty—such as those made from problematic materials or designs—a revision surgery becomes imperative to prevent further health complications.
For individuals who have undergone, or are facing the need for, hip revision surgery due to issues with their implant, legal options may be available. Even if the specific hip implant has not been officially recalled, patients may still have grounds for a lawsuit against the manufacturer.
This legal action can seek compensation for various damages, including medical expenses, pain and suffering, lost wages, and other related costs. It’s essential for patients and their families to consult with defective hip replacement lawyers to explore their rights and potential for a successful claim.
Types of Hip Implant Materials
Hip implants are designed using various materials, each with its own benefits and potential risks. The choice of material affects the implant’s durability, wear characteristics, and suitability for different patients. Here’s a detailed look at the types of hip implant materials:
Metal-on-metal – Metal-on-metal implants consist of both the ball and socket components made of metal alloys, typically cobalt-chromium. These implants were initially favored for their high durability and the potential for a larger head size, which could offer greater stability and range of motion. However, concerns have arisen over the release of metal ions into the bloodstream, potentially leading to local tissue reactions, metallosis (metal poisoning), and other systemic effects. Consequently, the use of metal-on-metal implants has significantly decreased, and they are less commonly recommended.
Metal-on-polyethylene – Metal-on-polyethylene implants have a metal ball and a polyethylene socket. This type was among the earliest designs and has a long history of use. While generally durable, the metal-on-polyethylene implants can produce more wear debris than ceramic-on-polyethylene or ceramic-on-ceramic systems. Over time, the polyethylene wear particles can lead to osteolysis and implant loosening, potentially necessitating revision surgery.
Ceramic-on-ceramic – Ceramic-on-ceramic hip implants involve both the ball and the socket components made of ceramic material. Ceramics are known for their hardness and smoothness, leading to less wear compared to other materials. These implants produce very little debris from wear, reducing the risk of osteolysis (bone loss) and increasing the implant’s lifespan. However, there’s a slight risk of the ceramic fracturing under extreme pressure or due to impact.
Ceramic-on-polyethylene – In ceramic-on-polyethylene hip implants, the ball component is made of ceramic, while the socket is made from polyethylene (a type of durable plastic). This combination offers the smoothness of ceramic with the flexibility and shock-absorbing qualities of polyethylene. It generally results in less wear than metal-on-polyethylene systems, making it a popular choice for younger, more active patients.
Hip Replacement Complications
Complications from defective hip replacements, particularly those involving metal components, present significant challenges and health risks to patients. Among the most alarming symptoms of a malfunctioning metal hip implant is the production of abnormal noises such as “grinding,” “popping,” or “clicking” from the hip area.
These sounds often suggest that the implant’s components are abnormally interacting with each other, leading to friction and the potential release of metallic debris into the bloodstream. This debris can trigger metallosis, also known as metal poisoning, a serious condition that can have systemic effects on the body.
Other signs and symptoms of hip replacement failure include:
- Osteolysis: The loss of bone around the implant site can compromise the stability of the hip replacement, leading to pain and potential implant failure.
- Persistent Hip Joint Pain: Pain that persists well beyond the expected recovery period may indicate that the implant is not functioning correctly or that the body is reacting adversely to it.
- Sensory Changes: Unexplained changes in vision or hearing may be systemic reactions to metal ions released from the hip implant into the bloodstream.
- Numbness or Weakness: Constant sensations of numbness or weakness in or around the hip area can signal nerve damage or other complications related to the implant.
- Loosening or Dislocation: The hip joint or its components becoming loose or dislocated suggests that the implant is not securely integrated into the bone, affecting mobility and stability.
- Mobility Issues: Significant difficulty walking or performing daily activities, especially months or years after the surgery, can be a red flag indicating the implant’s failure.
- Revision Surgery: In many cases, the only solution to these complications is a second surgery to replace the faulty implant or correct the issues, which can be both physically and emotionally taxing for the patient.
Metal Hip Manufacturers
In this section, we explore notable manufacturers of metal hip replacement devices, especially those that have faced recalls and lawsuits due to complications experienced by patients.
Exatech – Exactech, a major international orthopedic device manufacturer based in Gainesville, Florida, has recently faced FDA recalls for several of its hip implant models, including the Acumatch GXL and Novation GXL systems. These recalls, classified as Class 2 Device Recalls, were issued due to defects related to material deterioration from improper factory packaging. Patients experiencing complications from these devices might qualify for legal action to seek compensation.
Zimmer (Biomet) – Zimmer, a leading manufacturer in the orthopedic device industry, faced significant challenges with its Zimmer Durom Cup, which was recalled due to a high failure rate that necessitated numerous revision surgeries. The recall spotlighted the company’s failure to provide surgeons with adequate instructions for the implant’s proper installation technique, a critical factor contributing to the device’s complications. Additionally, Zimmer’s acquisition of Biomet brought further scrutiny, particularly concerning the Biomet M2a Magnum. This metal-on-metal hip replacement faced numerous lawsuits due to design flaws that led to severe complications, such as metallosis, a condition caused by the release of metal particles into the body.
Smith & Nephew – Smith & Nephew, a prominent name in the medical device industry, encountered significant issues with its R3 Acetabular System, leading to a recall. This system, designed for hip replacements, exhibited higher than anticipated failure rates, compelling many patients to undergo revision surgeries. The core of the problem was identified in the metal liner component of the hip replacements, which was specifically targeted by the recall.
Stryker – Stryker, a leading entity in the medical technology field, faced significant challenges with its hip replacement products, notably the Rejuvenate and ABG II Modular-Neck Hip Stems. These products were recalled due to fretting and corrosion observed at the modular-neck junction. This issue had the potential to release metal ions into the body, causing adverse local tissue reactions among patients. In addition to these concerns, Stryker’s LFIT V40 Femoral Head encountered problems, marked by higher than anticipated reports of the head taper lock failing.
What is Metallosis?
Metallosis is commonly referred to as metal poisoning, or cobalt/chromium poisoning. The condition occurs after metallic components from hip replacements rub against one another resulting in the accumulation of metal in the body’s soft tissue. This condition has also occurred in patients that are sensitive to the implant, or for other unknown reasons. Over the last 40 years, this condition has been observed in an estimated 5% of metal hip replacement implant patients.
Certain metal on metal hip implants may cause pieces of metal to be worn off the device. The metal may cause damage to nearby bones and tissue. According to the FDA, these metal particles may even enter the bloodstream and cause problems in a patient’s heart, nervous system, skin, and thyroid gland. Thus, metal pieces of ions from metal on metal hip replacements present serious health risks.
The FDA recommends that anyone who undergoes a metal-on-metal hip replacement surgery be on the lookout for symptoms which may indicate a problem with their implant. These symptoms include:
- Pseudotumor
- Chest pain
- Shortness of breath
- Numbness
- Weakness
- Change in vision or hearing
- Fatigue
- Feeling cold
- Weight gain
- Change in urination habits
Patients who have any of these symptoms after a hip replacement surgery may be experiencing a reaction to the metal of the implant or an increase in the amount of metal in the bloodstream. You can find additional information about these symptoms on the FDA’s Information for Patients Who Have Metal-on-Metal Hip Implants.
Hip Replacement Lawsuits & Settlements
Several high-profile settlements have been reached in hip replacement lawsuits due to issues like device failure, complications, or increased metal ions in the bloodstream. Here are some notable settlements:
DePuy Orthopaedics (a subsidiary of Johnson & Johnson): In 2013, DePuy agreed to a $2.5 billion settlement to resolve lawsuits over its ASR XL and ASR Hip Resurfacing systems. Additional settlements were announced in subsequent years, increasing the total compensation.
Stryker: Stryker reached settlements in 2014 and 2016 related to its Rejuvenate and ABG II hip stems, initially agreeing to pay over $1 billion. The settlement was designed to compensate patients who required revision surgery due to issues with these devices.
Zimmer Biomet: Zimmer faced lawsuits over its Durom Cup hip replacement, leading to a settlement program announced in 2016. While the total settlement amount was not publicly disclosed, it was aimed at compensating individuals who needed revision surgeries.
Smith & Nephew: In 2016, Smith & Nephew settled claims related to its R3 metal liners, part of the R3 Acetabular System, although the total settlement amount was not widely publicized.
Wright Medical Technology: Wright Medical reached a settlement in 2016 concerning its Conserve, Dynasty, and Lineage hip implants, agreeing to pay $240 million to settle around 1,300 claims.
Biomet (now part of Zimmer Biomet): Biomet agreed to a $56 million settlement in 2014 to resolve claims related to its M2a Magnum hip replacements.
These settlements were aimed at compensating patients for medical costs, pain, suffering, and other damages resulting from the faulty hip implants. It’s important for individuals with hip replacements to stay informed about potential recalls or lawsuits related to their devices and consult with a defective hip replacement attorney if they experience complications.
Hip Replacement Lawsuit FAQs
Which hip replacement devices have been recalled?
Below is a list of major hip replacement manufacturers along with recalled devices. You may visit the links to learn more about each specific manufacturer/device.
- Johnson & Johnson (DePuy)
- ASR™ Hip Resurfacing System
- ASR™ XL Acetabular Cup System
- Smith & Nephew
- Modular Redapt Femoral Hip Systems
- Modular SMF
- R3 Acetabular System
- Stryker
- ABG II Modular Neck Stem
- Rejuvenate
- Wright
- Conserve Plus Cup
- PROFEMUR® Z Modular stem
- Zimmer
- Durom Acetabular Component
- Taper M/L Stem With With Kinectiv® Technology
What are the signs/symptoms of a defective hip replacement?
One symptom of a faulty metal hip replacement involves a “grinding,” “popping,” “clicking,” or otherwise abnormal noise around the location of the hip implant. This type of noise may indicate that components of the device are rubbing against one another. Friction between these metal components may cause pieces of debris to enter the bloodstream which in turn, may cause a potentially fatal condition known as metallosis. This is also referred to as “metal poisoning.”
Other signs and symptoms of hip replacement failure include:
- Osteolysis (bone loss around the hip replacement)
- Prolonged pain in the hip joint
- Changes in vision or hearing
- Constant numbness/weakness
- Loosening and/or dislocation of the joint or other components
- Significant difficulty walking after numerous months/years of receiving the replacement
- Necessary second surgery to correct issues
What are the health risks of having a defective hip implant?
As stated above, metal poisoning is one very serious condition associated with a defective metal hip implant. This condition is potentially fatal as it can cause issues with the patient’s heart, nervous system, thyroid gland, and other vital organs/functions.
Another serious health concern involves the formation of a pseudotumor which is often caused by adverse reactions to metal debris. This adverse health issue may also be fatal.
Additionally, when a hip implant is defective, the patient will often have to undergo one or more additional surgeries to correct issues. These additional surgeries are known as “hip replacement revision surgery,” which in itself, is a health risk. Hip revision surgery is a health risk because it exposes a patient to additional risks of infection, heart attacks, blood clots, and more.
Other health risks involved with defective hip implants include:
- Permanent disability, or significantly reduced mobility
- Prolonged chronic pain
- Blindness/reduced vision
Is a device recall required for a lawsuit?
No, certain devices have not been recalled but are still subject to litigation due to the high rate of failure and patient injury. For example, the DePuy Pinnacle hip replacement has not been recalled, yet the manufacturer(s) (Johnson & Johnson and DePuy) are currently facing almost $2 billion in lawsuits due to injuries from this device.
What other devices are subject to litigation?
If the hip replacement is made of metal and caused injury due to device failure, there’s a good chance you’re eligible to receive compensation regardless of whether or not there was a recall. Below are some additional (non-recalled) metal hip implants linked to serious patient injury.
- Zimmer/Biomet M2a Magnum
- DePuy Pinnacle
Can the manufacturers be sued?
Yes, absolutely! If you were injured by one of the devices listed above, or another hip replacement made of metal, there’s a good chance that you’re entitled to compensation for your injuries. Since your injury occurred due to a defective medical device, the manufacturer is at fault, and thus, is legally liable. With that said, there’s a time limit on your claim; so, it’s important to seek legal and medical advice as soon as possible.
What does it cost to file a lawsuit against the manufacturer?
Nothing. If you or someone you know have been affected by a defective metal hip implant, you’re eligible for a free case review and pay nothing until we win your case and collect a settlement.
Is there a statute of limitations on hip replacement lawsuits?
Yes. The statute of limitations will depend on several factors such as: the type of device, the state where it occurred, when the injury was discovered, if/when you had hip revision surgery etc. You’ll need to consult with an attorney to determine the exact statute of limitations on your claim.
Who’s eligible for compensation?
Individuals are eligible to file a lawsuit against the manufacturer as long as they meet the following criteria:
- You were injured or significantly affected by a metal-on-metal hip implant.
- The hip replacement procedure occurred in the United States.
- Your claim falls within the statute of limitations.
Please note, these are general guidelines; it’s impossible to provide absolute answers without an actual legal consultation
How can I receive compensation?
Many of the lawsuits against metal hip manufacturers are consolidated into Multi-District Litigation (MDL) cases. MDL’s are similar to class action lawsuits in that they have the potential of providing a high level of compensation to a massive number of affected individuals. If you were injured by a faulty metal hip replacement, there’s a good chance your case is eligible for one of the existing MDL cases against the product manufacturers. Our lawyers will help you file your claim and represent you as part of a Multi-District Litigation case anywhere in the United States.
What type of settlements can I receive?
To put this in perspective, here’s a short list of some of the settlement amounts and/or estimates (as of 2019)
- Zimmer paid close to $400 Million so far with litigation still pending.
- Johnson & Johnson/DePuy paid a large settlement of $2.5 Billion for 8,000 claims.
- Stryker paid settlements of $1.43 Billion with an average of $600,000 per claim.
- Biomet, a company that was acquired by Zimmer in 2014, paid $56 Million with thousands of pending claims.
Talk to a Hip Replacement Lawyer
Given these challenges, patients suffering from the fallout of defective hip implants may find recourse through legal action. The hip replacement lawyers at Di Pietro Partners, PLLC, with its deep experience in medical malpractice and mass tort claims, stands ready to assist. Our team, bolstered by board-certified physicians, offers an unparalleled understanding of the medical intricacies involved, ensuring a robust evaluation of your case.
If you, or someone you know, are grappling with complications from a defective hip implant, Di Pietro Partners, PLLC invites you to reach out for a free consultation. Our commitment is to advocate for your rights, aiming to secure just compensation for the hardships endured due to faulty hip replacements.
Our extensive experience with cases involving major manufacturers—such as DePuy, Stryker, Zimmer, Biomet, Smith & Nephew, Wright, and Exactech—positions us uniquely to navigate the complexities of your claim effectively.