Wright Hip Lawsuit Settlement Funding
Pre Settlement Funding on Recalled Wright Hip Implant Litigation
Wright Hip Lawsuit Funding
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Wright Medical Technology has been a worldwide name since its launch. The Tennessee-based company is known for knee, hip, ankle, and foot devices. 60 percent of the company’s sales come from its hip and knee implants. Wright Medical has been in the industry since 1950, and has contributed many innovations in the orthopaedic industry.
Like its competitors, Wright Medical has been under a lot of scrutiny for its metal-on-metal hip implants. While its products differ from those in the market, they share common risks and complications with other all-metal hip devices such as pain in the groin or hip area, loosening of the implant, metallosis, high metal toxicity levels, among many others that also require revision surgery to correct.
These complications experienced by patients is also the main reason for the lawsuits against the company. Numerous recipients of the Conserve Hip Systems and the Profemur Z Stem have reported complications which often needed to undergo revision surgery. Claims against the company include negligent and faulty designs, failure to inform patients and doctors regarding risks, concealment of pertinent information that was already known to the company, among other claims.
Wright Medical is expected to gain more lawsuits against them due to the growing number of patients that have gone through complications and troubles with the devices. A multidistrict litigation was made in February 2012. The litigation is overseen by Judge William S. Duffey, Jr. in the United States District Court for Northern Georgia, with over 70 pending cases included in the litigation as of January 2014.
While the multidistrict litigation is only limited to cases concerned with Conserve Total Hip Implant System, Conserve Total A-Class Advance Metal Hip Implant System, and Conserve Resurfacing System, an April 2012 court order issued statements that some lawsuits are also allowed to join the litigation. These lawsuits, however, are limited to those patients that have suffered injuries associated with all-metal design problems from the use of the Profemur System that was connected to a Conserve Total Hip Implant System or a Conserve Total A-Class Advance Metal Hip Implant System.
Wright Lawsuits and Litigation
Numerous patients have filed lawsuits against Wright Medical Technology due to reports of early device failure, pain, bone and tissue damage, infections, and excessive metal ions in the bloodstream. The faulty design of the device also requires some patients to undergo revision surgery to address the various problems.
Thousands of people have received Conserve Plus and Profemur Z Stem, and some of which have filed lawsuits against the company after necessitating revision surgery to correct complications like metallosis, loosening of the prosthesis, severe pain, device failure and device fracture. Plaintiffs have filed lawsuits with claims of negligence and faulty design against Wright Medical Technology.
After a 2007 investigation, Wright Medical was sued by the federal government for questionable business practices. This included allegations of bribing doctors to use the company’s products. The company avoided admittance of any wrongdoing by paying fines worth $7.9 million in 2011.
In 2011, a man filed a lawsuit against Wright Medical after the titanium neck of the Profemur Z Stem he was implanted with had fractured — while he was dressing up for work. Emergency surgery was needed because his hip gave out, with the man suffering from extreme pain. The emergency surgery involved removal of the fractured titanium fragments. Two years later, Wright was able to settle two lawsuits regarding its Profemur products.
Because of the insurmountable amount of lawsuits against Wright Medical for the Conserve hip replacement systems, the cases were consolidated under a multidistrict litigation in the United States District Court for Northern Georgia in February 2012, presided by Judge William S. Duffey, Jr. There are over 70 pending cases in the litigation as of January 2014.
Complaints included high levels of metal toxicity in the bloodstream, which can lead to implant loosening and device failure due to its faulty all-metal design. Parties have agreed, after the consolidation of the multidistrict litigation, that the cases would be limited to those concerned issues concerned with the all-metal design of Conserve Total Hip Implant System, Conserve Total A-Class Advance Metal Hip Implant System, and Conserve Resurfacing System.
A court order in April 2012 stated that plaintiffs concerned with the company’s Profemur System can also find their cases to be transferred in the aforementioned multidistrict litigation. Although the court ordered that those cases to be transferred are only limited to injuries associated with metal-on-metal design problems. It was also added that these cases must involve a Profemur System which was connected to a Conserve Total Hip Implant System or a Conserve Total A-Class Advance Metal Hip Implant System. Plaintiffs that claim neck failure in the Profemur devices can still opt to file claims in federal or state court, outside of the multidistrict litigation.
Wright Medical settled a case in November 2013 included allegations of premature failure of a Profemur hip implant. The amount was not disclosed. The case was set for trial in the United States District Court for the Middle District of Georgia, until the settlement was made a few days prior.
Plaintiffs who have filed lawsuits against Wright Medical have claimed that the company failed to properly design and adequately test the devices, manufactured defective devices, improperly marketed and misrepresented the devices as safe and durable in spite knowing of its serious side effects and failure rates, and failed to properly warn or inform patients and surgeons about its risks.
Background on Wright Medical Technology
Based in Arlington, Tennessee, Wright Medical has been in the orthopaedic medical device industry since 1950 because of its joint implant devices. Most of the company’s sales come from its hip and knee products, with a figure of about 60%. Wright not only designs and manufactures their products but has also been marketing and selling them in over 60 countries. In the first eight months of 2012, the company had $480 million in sales. The company has branches in Canada, Japan and Europe, with approximately 1,300 employees.
The roots of the Wright Medical Group have been in the hips and knees products, although the company is known for foot and ankle medical devices. The company currently controls approximately 2 percent of the hip and knee market in the United States.
The company contributed a lot to innovations in hip replacement systems, including ceramic hip systems, hard-bearing surfaces and proprietary neck modularity. The Lineage products, specifically the liners and femoral heads use alumina oxide ceramic for these components.
Wright Hip Systems
Wright Medical Technology carries numerous hip replacement systems varying in materials as well as category, Components are made of ceramic, metal, and/or polyethylene plastic. These products are intended to address a variety of hip problems including osteoarthritis, trauma, and fractures, among many others. The different hip replacement systems can either be used with cemented or non-cemented techniques.
The resurfacing hip systems include the Conserve Femoral Surface Replacement and the Conserve Femoral Surface Replacement, while the acetabular hip systems have more products under the category, such as Dynasty Acetabular Cup System, Inteseal Acetabular Cup System, Procotyle Acetabular Cup System, Conserve Total A-Class Advanced Metal with BFH Technology, Gladiator Bipolar Hip System, Lineage Acetabular Cup System (made from polyethylene) and Conserve Total Hip with BFH Technology.
The femoral hip systems also have a number of products in its category, particularly, Perfecta Plasma Spray Stems, Perfecta RS Stems, Profemur E Hip Systems, Profemur FC Stem, Profemur LX ⅝ Stem, Profemur Plasma Z Hip Stems, Profemur Renaissance Stem, Profemur TL Total Hip System, Profemur Total Hip System, Profemur Z Hip Stems, Perfecta IMC Stems, Perfecta PDA Stems, Perfecta RS & IMC Slim Neck, and Perfecta Total Hip System.
Wright Medical Technology also offers products that can aid in revision surgeries, called Revision Systems. Under this category, there are three products from that the company offers; namely, Link MP Reconstruction Hip Stem, Profemur R Revision Prosthesis, and Profemur LX ⅝ Revision Stem.
Wright’s Conserve Hip System
While ceramic-on-ceramic products have given much success to Wright Medical Technology, the same cannot be said for its all-metal products. Wright’s Conserve product lines have caused numerous complications no different from the existing established complications from other metal-on-metal hip systems from various manufacturers.
The Conserve hip system is also prone to shedding of metal particles or debris from the implant. The metal ions are capable of travelling into the bloodstream or may cause tissue or muscle damage to areas around the implant. This gives a high metal toxicity which is a severe side effect for patients. High metal toxicity levels can give way to metal poisoning, tissue necrosis, loosening of the device among its other severe problems.
The Conserve product line was intended for the demand of more durable implants for younger people and for those with more active lifestyles. These Conserve metal-on-metal implants are designed to give better range of motion for patients that have low particle wear and tear, as well as to give long-term durability. Wright Medical Technology has claimed that the Conserve hip replacement systems line has excellent design that diminishes dislocation rates, as well as wear and tear of the product.
The ball size of the product is closely similar to the natural size of the large femoral head of the human anatomy. It allows patients to have a 169 degree motion. It is made of a high carbon, cobalt chrome cup and a cobalt chrome ball which are intended to reduce the wear and tear. The outside cup has a beaded and porous coating to allow bone growth. The femoral heads have varying sizes, ranging from 36mm to 54mm, which are the largest in the industry.
Because Conserve products have a design which has no need for a liner, the products are referred to as a monoblock design. The product comes in one piece, as compared to most all-metal products in the market that has more than just one piece to the implant. Wright Medical claims that products under the Conserve line curtails the risk of soft tissue impingement, which has the ability to develop into dislocation. Some studies have revealed that higher ball sizes result in fewer dislocations in patients.
Included in the Conserve hip replacement line are Conserve Plus Total Hip Resurfacing System (2009), Conserve Total Hip with BFH Technology (2003), and Conserve Total A-Class Advanced Metal with BFH Technology (with patent pending). The Conserve Total Hip acetabular cups and balls are designed in such a way that they can be used with different stems, including the Profemur Z Stem.
Unfortunately, the Conserve Plus Total Hip Resurfacing System has shown higher failure rates than normal. Exponentially adverse complications can also come about when the Conserve Total Hip is used together with the Profemur Z Stem.
Wright’s Profemur Z Stem
The Profemur Z is a modular neck and stem system. The Profemur Z Stem’s femoral stem works in such a way that the stem would fit in the thigh bone, and is connected to the neck, which is then connected to the ball. The Z Stem is constructed for use in minimally invasive surgical techniques. The design was made so that the insertion process into the bone is simplified.
Titanium alloy is used for this product’s modular neck and stem system. The stem of the Profemur Z is dual tapered, with the upper half shaped like a rectangle. The stem’s surface is grit-blasted, which generates a rough surface to allow the stem to have a better bond with the bone.
The system includes the stem, with six different options for the interchangeable neck pieces. The neck pieces have two variations of lengths. This system’s modular necks and stems grants surgeons more ways to customize the hip system to better suit each patient; specifically, allowing a better fit through customized lengths. This is a big plus especially for intricate revision surgeries.
The Australian National Joint Registry has reported that 1 out of 9 Profemur Z Stem patients were required to undergo revision surgery because of device failure. Included in the report were complications such as corrosion, femoral neck fracture, and fretting — wear damage caused by two opposing surfaces are rubbed together.
The Profemur Z Stem is also under a lot of close examination from the public eye because it is highly likely to fracture, thus resulting in early failure. The orthopaedic community has expressed great concern for the product’s stability and design integrity. Similar to metal ball and metal cup issues, the Profemur Z system’s metal necks and stems can also create a lot of friction.
Wright Medical’s Conserve Plus
No recalls have been issued yet regarding the Conserve Plus even though it is highly similar to DePuy Orthpaedics’ ASR. The two products from the different manufacturers both are cementless, monoblock devices with cups that bear large femoral heads made of cobalt chromium.
Both products also have beaded porous coating for development of bone growth. The two systems are also marketed towards younger individuals and patients that have active lifestyles due to features regarding better range of motion. The two products also have reports on remarkably high revision rates.
The National Joint Registry of England and Wales have reported that the five year revision rate for the Conserve Plus is 8.36 percent. The product is second to DePuy’s ASR, carrying a 9.63 percent five year revision rate.
FDA Recalls, Warnings and Reports
The FDA has obtained over 200 adverse event reports of device failure, pain in the hip and groin areas, loosening of the implant, and high metal toxicity levels in the blood due to its metal-on-metal design.
The FDA, in the past, has warned the public regarding the adverse complications that can be obtained by patients through the use of metal-on-metal hip implants. Conserve hip replacement systems are no exception to the severe effects, such as pain in the groin, hip, or leg, limp or increased difficulty in walking, and swelling either in or near the hip joint.
The Wright Medical Profemur Total Hip System was approved by the FDA through the 510(k) premarket approval (PMA) program. This program basically approves any product that is “substantially equivalent” to a product that was already approved by the FDA and is in the market. The 510(k) fast forwards the approval process since the product pending for approval no longer needs to go through clinical trials and human testing. The Conserve Plus Total Hip Resurfacing Hip System was also approved through the premarket approval program.
However, this approval system has proved to be less efficient since many products that have gone through the approval system have shown side effects and complications, which gives much more complication not only for the FDA and the manufacturers, but for the patients and healthcare professionals as well.
Because all-metal hip devices are also popular in terms of its ability to bring about metallosis in patients with the implants, the FDA also warned the public regarding other problems that can occur because of the superfluous amount of metal particles in the bloodstream. These other problems include chest pain and/or shortness of breath, numbness, fatigue, weight gain, changes in vision or hearing, feeling cold, urinary trouble, and other problems associated with the heart, nerves, thyroid, and kidney.
Studies have revealed that hard-bearing surfaces like ceramic or metal have less particle wear when it is paired with another device that has hard-bearing surfaces, as compared to soft-bearing ones like polyethylene plastic. Wright states that matching ceramic parts have less wear and tear and therefore produces less debris in comparison to ceramic-on-plastic or metal-on-plastic hip systems. After nine years, post-study of the data, alumina-on-alumina hip devices have shown a 97.8 percent survival rate. However, this does not eradicate the problems associated with the ceramic-on-ceramic hip devices with reports of joint squeaking and tendency of fracture from patients that received the specific implants.
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