Fighting Dangerous Medical Device Manufacturers Since 1976
Hundreds of thousands of Americans have received surgically implanted orthopedic devices to correct damaged joints. Many of these patients received metal implants because they were supposed to be more durable, longer lasting, and provide a greater range of motion than older model implants made up of combinations of metal, plastic, and ceramics. However, these marketing claims have been proved false, as thousands of individuals have suffered serious complications from an orthopedic joint replacement surgery. Metallosis occurs as a side effect in metal-on-metal joint replacements. If you or some you love have suffered toxic effects from a metal implant, contact an Orthopedic Joint Replacement Lawyer from The Carlson Law Firm.
Patients should never have to wonder if a medical device is safe or not, but unfortunately, defective medical devices do exist and are still widely used. If you have received an orthopedic joint replacement device and have experienced symptoms like swelling at or near the joint, a limp or other change in your ability to walk, or extreme and continuous pain in the groin, hip, or leg, contact an Orthopedic Joint Replacement Lawyer at The Carlson Law Firm right away. In addition, our mass tort team has the resources you need to get the justice you deserve. You have legal options and may be eligible to sue the manufacturer of the defective product for damages.
FREE consultations are available when you call (254) 526-5688.
What is an Orthopedic Joint Replacement?
Joint replacement surgery removes damaged or diseased parts of a joint. The surgery replaces them with new, man-made parts. The goal of the joint replacement surgery is to relieve pain, help the joint work better and improve walking and other movements. Orthopedic joint replacements can be total or partial.
Total replacement and partial replacement surgeries essentially treat two different types of issues. In contrast, total joint replacement surgeries typically treat degenerative arthritis, while partial replacements treat injuries. Replacement materials are often made from different types of metals:
- Chromium
- Cobalt
- Nickel
- Titanium
- Molybdenum
If you received a metal-on-metal joint replacement, contact The Carlson Law Firm. An orthopedic joint replacement lawyer can help you get the compensation you deserve. Additionally, we can help begin your journey to recovery.
What is the Chief Complaint about Joint Replacement Devices?
Patients with metal-on-metal joint replacements report serious complications stemming from the device. For example, as the devices wear, they release metallic particles into the body that can cause muscle and tissue damage. The metal ions released into the body can cause the implant to loosen, pain and illness.
Metal-on-metal joint replacements have a greater risk of loosening and early failure because the metal particles weaken nearby bone and tissue.
What is Metallosis?
Metallosis is a type of metal poisoning that occurs in joint replacement devices with metal components. For example, metal-on-metal joint replacements rub together, they release microscopic metal particles into the blood and surrounding tissues. This causes toxic levels of metal to build in the body resulting in metallosis, or metal poisoning. In particular, the condition damages surrounding tissue, bone and nerves.
While people can get metal poisoning through their environments and diets, metallosis should not be an expected side effect of a surgery intended to improve your quality of life.
Metallosis causes the following symptoms:
- Heart problems, including heart failure
- Depression, anxiety and other mental problems
- Visual impairment that may lead to blindness
- Cognitive impairment
- Nerve damage
- Thyroid problems
- Auditory impairment that may lead to deafness
- Skin rashes
- Noises coming from replaced joints
- Infection
- Loose implants
If you or a loved one suffered metallosis injury after an orthopedic joint replacement surgery, contact The Carlson Law Firm. An Orthopedic Joint Replacement Lawyer is ready to take your call and get you started on the road to justice. Call today to schedule a free case evaluation.
Who is at risk for developing metallosis?
Those with metal-on-metal joint replacements are at-risk for developing metallosis. However, some people may be at an even higher risk suffering problems from excessive amounts of metal ions in the blood.
According to the FDA, there are several factors that lead to higher risks of suffering adverse events from replacement surgeries:
- Women are at a higher risk than men
- Bilateral implants
- Femoral heads 44mm or smaller
- High doeses of corticosteroids
- Renal insufficiency
- Suppressed immune systems
- Suboptimal alignment of device components
- Suspected metal sensitvity
- Severely overweight
- High levels of phystical activity
What other complications can arise from metal-on-metal joint replacements?
In addition to toxicity, studies show that metal-on-metal implants deteriorate faster than other types of devices. Many patients who have undergone joint replacement surgery with defective devices have suffered a number of debilitating complications, including:
- Excruciating pain after surgery
- Muscle and tissue damage
- Implant dislocation
- Premature failure of their devices
- Severe infection
- Bone loss
- Metallosis (buildup of toxic metals in the blood)
- Pseudotumors
Approximately 1 in 12 patients with these devices will need corrective surgery within five years of initial implantation. These “revision” surgeries to remove the old devices and insert new ones can be both painful and expensive. We believe that injured people have endured enough and should not have to shoulder this financial burden.
What does the FDA say about Metallosis?
According to the FDA, metal-on-metal joint replacements pose more risks than other implants because of the metal ions that enter the tissue. In 2012, an 18-member panel found little reason for doctors to continue using metal-on-metal devices. This opinion after two days of hearings to investigate the safety of metal-on-metal joint implants. The hearing came after nearly 17,000 patients injured by joint implants reported their injuries to the FDA.
The consensus among doctors was that there was no use for metal-on-metal implants, but the FDA did not recall the devices. Instead, panel members asked for more studies. Additionally, the panel agreed that doctors should inform patients of the problems associated with these devices.
Who are the Candidates for Orthopedic Joint Replacement Surgery?
In 1998, criteria for determining which patients were good or bad candidates for partial joint replacement. The ideal patient is:
- Older than 60 years old
- Less than 180 pounds
- Less active
- Has a good range of motion before surgery
- Has minimal deformity
A study published in Arthritis & Rheumatism in 2013 determined which patients benefit the most from a total joint replacement surgery. The ideal total joint replacement candidate has:
- High level of presurgical pain
- Only one “troublesome” hip or knee
- Better overall health (no other health conditions)
- Joint damage caused by OA as opposed to inflammatory types of arthritis
On the other hand, doctors have also determined who is not a good candidate for knee replacement. To that end, you may not be a good candidate if:
- Symptoms are not related to joint disease
- Your weight is too much for the artificial joint to support
- You have fragile skin over your knee
- You have a severe illness, infection or terminal disease
Types of Defective Joint Replacement Devices
If you have experienced complications with any of the following orthopedic implants, we encourage you to contact an orthopedic joint replacement lawyer at The Carlson Law Firm:
- Any Metal-on-Metal Hip Implant
- Omnilife Apex ARC and Apex K2 hip stems
- DePuy Pinnacle Hip
- DePuy Preservation Knee System (with LPS sleeve)
- Stryker Rejuvenate, ABG II or Accolade Hip Systems
- Wright Pro-femur
- Zimmer Nex-Gen/ High Flex Knee
- Smith and Nephew Journey Knee, Genesis II, R3 Acetabular cup, or Birmingham Hip
- Any other Smith and Nephew product
What is the Status of Orthopedic Joint Replacement Lawsuits?
Thousands of people filed orthopedic joint replacement lawsuits. Those harmed by the devices allege that companies who recalled the products knew about fault designs and did not warn patients of the risks of the implants. When companies settle these cases, they typically only settle with people who received the implant prior to a recall.
Although most lawsuits involving metal-on-metal implants have resolved, as of May 2018, nearly 14,000 hip cases were still pending across the country. Over time, juries awards have ranged from the millions to more than $1 billion. Some implant manufacturers have resolved thousands of lawsuits through settlement agreements in recent years. Multidistrict Litigation (MDL) involving at least two manufacturers is still in the early stages. MDLs allow several lawsuits, even thousands at a time, to make the court process faster and less expensive for all parties involved.
If you need legal representation for your joint replacement injuries, contact an orthopedic joint replacement lawyer from The Carlson Law Firm. Scheduling a free case evaluation is your first step to recovering proper compensation.
Joint Replacement Recall
While the FDA rarely initiates recalls, defective equipment recalls may be initiated by the FDA or the manufacturer. In addition, manufacturers know that they are legally responsible for providing a safe product. They also have a duty to warn the public if a device fails, has negative side effects or doesn’t do what it claims. These are the reasons manufacturers voluntarily recall defective products.
Between 2002 to 2013, there were 578 recalls from six major joint replacement manufacturers, Biomet, DePuy, Smith & Nephew, Stryker, Wright and Zimmer. Of the top manufacturers, Stryker had 231 recalls—the most out of the top six. DePuy came in second with 150. The implant products recalled include:
- DePuy ASR Acetabular & Resurfacing System
- Stryker Rejuvenate and ABG II Hip Recall
- Smith & Nephew (S&N) R3 Acetabular, Modular SMF, Modular Redapt Femoral Hip Systems
- Wright Conserve Plus and Profemur Z Hip Stem
- Zimmer Durom Acetabular Compenent
The FDA recalled three products between 1993 and 2003. However, most recalls were voluntary by implant manufacturers. In fact, most of the recalls occurred between November 1, 2002, and July 23, 2013. Smith & Nephew recalled their hip systems in 2016.
What were the Reasons for Joint Replacement Recalls?
The FDA relies on manufacturers to monitor the safety of their devices and report problems after the products hit the market. This type of lax regulation gives manufacturers little incentive to make safety a priority. In fact, studies, show that manufacturers either miss or ignore device failures. In the case of metal-on-metal joint replacements, many of the companies issued voluntary recalls. If one of the following devices were surgically implanted in your body and led to serious ailments, contact an orthopedic joint replacement lawyer from The Carlson Law Firm. We can help you recoup compensation for your injuries.
Zimmer Durom Cup Recall
Zimmer temporarily recalled the Durom Cup in July 2008. Over 12,000 people in the United States had the Zimmer Durom Cup implanted during their hip replacement surgery. The Durom Cup was introduced to the U.S. market in 2006. Unlike a traditional hip replacement component, the Zimmer Durom Cup is made from a single piece of material.
DePuy ASR Hip Recall
DePuy voluntarily recalled its Articular Surface Replacement (ASR) hip systems in 2010 after unpublished data from the U.K. found that metal devices had more problems than older devices and were less durable. In 2011, the National Joint Registry of England and Wales published a report that 29 percent of the replacement or removal of DePuy’s ASR implant occurred after just six years. Comparatively, these findings taken into context with the 9.5 percent failure rate of all-metal hip implants shows that the ASR was a seriously problematic device.
In January 2013, the jury in the first ASR trial heard evidence that at the time of the recall DePuy knew that within five years 40 percent of ASR implants would fail.
Stryker Rejuvenate and ABG II Hip Recall
In July 2012, Stryker issued a voluntary recall. The voluntary recall came just three years after the Rejuvenate and ABG II hip systems were approved by the FDA. However, the recall came after Stryker discovered the metal necks and stems of the devices were prone to corrosion and fretting. Further, this breakdown could release excessive metal debris into the body and damage surrounding bone and tissue.
Smith & Nephew (S&N) R3 Acetabular System Recall
U.K.-based Smith & Nephew (S&N) released the R3 Acetabular System Recall in Europe and Australia in 2007. Eventually, it was released in the United States in 2009. By the summer of 2012, the company issued its first international recall of the R3 system’s metal liner. The recall came after complications such as failure, loosing, pain, dislocation and metal sensitivity.
The metal liner was marketing as durable and wear-resistant. However, S&N said the metal liner did not perform as well as the company expected. By the time S&N issued the recall, between 3,000 and 4,000 Americans received the metal liner.
Smith & Nephew Modular SMF and Modular Redapt Femoral System Recall
Smith & Nephew launched is Modular SMF hip system in 2008. In addition, it launched its Modular Redapy Femoral System in 2012. The company recalled both of these hip implant systems on Nov. 15, 2016. This recall was the result of higher than normal adverse events and complaints stemming from dislocation, fractures and other complications that could require surgery to correct.
Because of this company’s failure to protect the public harm, thousands of lawsuits were filed. Over the last several months, the number of lawsuits involving S&N hip replacements continues to grow. The Carlson Law Firm’s Orthopedic Joint Replacement Lawyer is still accepting Smith & Nephew hip cases.
A Carlson Law Firm Orthopedic Joint Replacement Lawyer can Help
The Carlson Law Firm is now accepting cases involving defective joint replacement devices. If you or a loved one have experienced complications after receiving a knee or hip replacement, please contact an orthopedic joint replacement lawyer to talk about your legal options. Moreover, you may be able to obtain compensation for your pain and suffering, medical expenses, lost wages, and more.
If you developed metallosis or another ailment contact The Carlson Law Firm to schedule a free consultation with an orthopedic joint replacement lawyer. Although metal-on-metal joint replacements are intended to improve the lives of those who receive them, they are also associated with serious harm. Even though victims of who received metal-on-metal joint replacements prior to the recalls are eligible for an orthopedic joint replacement lawsuit, those who had devices placed after recalls were issued are not.
Above all, our firm has more than 40 years of assisting personal injury victims. We have the in-house resources to take metal-on-metal joint replacements cases to trial to get you the compensation you deserve—should it come to that.
Contact an experienced Orthopedic Joint Replacement Lawyer today by filling out an online case evaluation form.