The side effects of Smith & Nephew’s hip and knee replacement systems are infections, fractures, and dislocations requiring corrective surgery. Our law firm is working with some of the leading Smith & Nephew’s Hip and Knee replacement attorneys in the United States. A claim and/or Smith & Nephew lawsuit can be filed on your behalf and there is no fee until you receive an award or a Smith & Nephew settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.
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Smith & Nephew’s hip and knee replacement systems are designed to mimic the movement of the hip and knee joints while providing durability through the company’s OXINIUM (oxidized zirconium) technology. The company manufactures medical devices for the entire range of hip and knee replacement surgeries. There are three types of hip surgery; total hip replacement, partial hip replacement, and hip resurfacing. In a total hip replacement surgery, both the ball and the socket are replaced. In a partial hip replacement surgery, only the ball is replaced. In a hip resurfacing procedure, the cup is replaced while the ball is reshaped and capped. Smith & Nephew’s R3 Acetabular System is used in total and partial hip replacements while the Birmingham Hip is used in resurfacing procedures. The company’s Genesis II Knee System and JOURNEY Bi-Cruciate Stabilized Knee System are used in total and partial knee replacement surgeries. Unfortunately, the design of these hip and knee replacement systems have caused patients implanted with these devices to suffer pain, infection, fracture, and dislocation.
Hip and Knee Replacement System Recalls
In recent years, device failures have caused Smith & Nephew to recall a number of its hip and knee replacement systems. In 2003, the company recalled a knee replacement system requiring 26 percent of patients implanted with the device to undergo corrective surgery. In 2007, another knee replacement system recall was issued. In 2010, the company recalled about 40,000 defective tibial baseplates. In some cases, these baseplates failed only six months after implantation. The most recent recall was in 2012 for the R3 Acetabular System, a metal-on-metal hip replacement system.
Metal-On-Metal Hip Replacements
In 2009, Smith & Nephew released the R3 Acetabular System for sale on the market in the United States. Between 3,000 and 4,000 R3 Acetabular Systems, were distributed to the American market before the device was recalled. This hip replacement system used the metal ball in metal cup method. This method has also been used by other medical device manufacturers including Biomet, DePuy, Stryker, and Zimmer. More than 500,000 Americans have received one of these metal-on-metal hip replacements since their release on the market. However, government reports and medical studies have concluded that these metal-on-metal joint replacements have a higher than normal failure rate. Such devices have a high failure rate because the metal surfaces grind on each other as the patient moves and eventually the device corrodes. This corrosion can cause pain, infection, fracture, and dislocation. Metallosis is also a common side effect of this class of medical device, but has not yet been linked to Smith & Nephew hip and knee replacement systems. Metallosis occurs when the metal ball and metal cup grind creating metal debris, which builds up on soft tissue. Injuries caused by Smith & Nephew hip and knee replacement systems can be painful and costly. The treatment of a defective device often includes corrective surgery and physical therapy. If you have experienced any adverse side effects from the R3 Acetabular System, Birmingham Hip, Genesis II Knee System, JOURNEY Bi-Cruciate Stabilized Knee System, or any other Smith & Nephew device you should contact a personal injury lawyer.
Smith & Nephew Hip and Knee Replacement System Side Effects
In recent years, the number of hip and knee replacements has increased with an increasing number of patients under fifty-five years old. Medical device manufacturers have tried to supply this younger and more active market with durable implants. However, the mass production of implants and the faulty design of metal-on-metal implants have caused many patients adverse side effects.
Smith & Nephew medical devices have been linked to minor and major adverse side effects. Minor side effects include allergic reaction, inflammation, and pain. Infection is a more serious side effect that affects about one percent of patients after surgery. If the infection is diagnosed and treated shortly after the surgery, then doctors can clean the wound and treat it with antibiotics. However, if the infection is diagnosed too late, then the implant may need to be removed and re-implanted after the infection is treated. Patients implanted with the R3 Acetabular System may be at a greater risk of infection because the Food and Drug Administration has issued warnings to Smith & Nephew that its manufacture of the device did not meet minimum sterilization requirements.
Debris Build Up
Debris is created every time an implant moves. This debris can cause adverse side effects when the human body reacts negatively to it. Metal-on-plastic implants create polyethylene particles that can lead to a condition named, osteolysis. When this condition is present the body treats the debris as foreign and releases cells to dissolve the debris. However, these cells dissolve the bone surrounding the implant, which eventually causes the device to fail. Metal-on-metal implants create metal debris that can lead to a condition named, metallosis. When this condition is present metal debris builds up on the soft tissue surrounding the implant and starves it of oxygen. This build up of metal debris can cause metal poisoning and cause the device to fail. While metallosis is common to metal-on-metal devices, it has not yet been affirmatively linked to Smith & Nephew devices.
Other Serious Side Effects
Other serious side effects of Smith & Nephew hip and knee replacement systems include ossification, osteonecrosis, loosening, fracture, dislocation, and death.
Ossification occurs when soft tissue surrounding the implant calcifies. Ossification is present in about fifty percent of implant patients but only about ten percent experience its adverse side effects including tenderness, swelling, and decreased range of motion. Osteonecrosis occurs when the implant deprives the surrounding bone of blood. When bone is deprived of blood it dies and collapses causing the device to fail. A hip or knee implant can also loosen over time from wear and tear, osteolysis, or metallosis. Additionally, weakened bones surrounding an implant can fracture over time. About one percent of patients experience a fracture after a first surgery and four percent after a revision surgery. About five percent of patients experience a dislocation after a first surgery and twenty percent after a revision surgery. Finally, according to the Iowa Orthopedic Journal, about one percent of patients died during a first surgery and about 3 percent during a revision surgery. Although hip and knee surgeries have become more common, they do pose serious risks especially when the implanted medical device is not sterile or defective.
Smith & Nephew Medical Studies
Dr. Derek McMinn is a British orthopedic surgeon who introduced metal-on-metal hip replacements. Smith & Nephew bought McMinn’s design and now manufactures the device under the name, Birmingham Hip Resurfacing. In 2004, McMinn published a paper in the Journal of Bone and Joint Surgery addressing metal-on-metal implants stating, “caution still needs to be exercised until longer term results are available.” Unfortunately, medical device manufacturers such as Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer have not followed Dr. McMinn’s advice and now more than 500,000 Americans have metal-on-metal hip implants. It has now been determined that such metal-on-metal have a higher than normal failure rate. According to the British Medical Journal, about twelve percent of metal-on-metal resurfaced hips and fourteen percent of metal-on-metal total hip replacements fail after seven years while hip replacements made of other materials only fail at a rates between three and five percent after seven years.
FDA Reports On Smith & Nephew Devices
The Food and Drug Administration (FDA) has received more than 16,800 reports of adverse side effects from metal-on-metal implants. Despite the large number of negative metal-on-metal implant reports; the FDA approved Smith & Nephew’s R3 Acetabular System in 2009. The hip replacement system was approved under the FDA’s 510(k) approval process. Under this process, any product that is “substantially equivalent” to a product already sold on the market is approved without any additional testing. The FDA approved the metal-on-metal hip replacement because it determined that the device was “substantially equivalent” to ceramic and plastic hip replacements already on the market. Even though metal-on-metal devices look similar to ceramic and plastic devices, the risks of metal-on-metal devices are remarkably more serious. Now, more than 500,000 patients have been implanted with dangerous metal-on-metal devices that have not undergone additional testing. The FDA has finally recognized the danger posed by these hip and knee replacement systems and has ordered manufacturers to begin post-market studies on the devices.
Medical Studies On The Effect Metal Ions
In a 2011 clinical trial published in the Journal of Bone and Joint Surgery, doctors found that a large diameter Smith & Nephew hip replacement caused twenty percent of patients implanted with the device to have raised concentrations of metal ions in their bloodstream. High concentrations of metal ions in the blood stream have been linked to metal poisoning and genotoxicity. This is especially dangerous for pregnant women implanted with metal-on-metal devices because the metal ions have been found in umbilical cord and placenta blood.
Medical Studies On Joint Surgeries
In 2003, the Iowa Orthopaedic Journal reviewed data from about 5,000 joint surgeries. The researchers discovered that while the mortality rate for patients undergoing first time surgeries was about one percent, the mortality rate for patients undergoing revision surgery increased to about three percent. Revision surgeries have been proven to pose more risks than first time surgeries. For example, revision surgeries increase the risk of fracture from one to four percent and the risk of dislocation from five to twenty percent. Therefore, Smith & Nephew hip and knee replacement systems are not only dangerous because of device failure, but they also expose patients to the greater risks posed by revision surgeries.
Smith & Nephew Lawsuits
Smith & Nephew is one of many hip and knee replacement system manufacturers that are now the subject of serious litigation across the country. The primary allegation of many plaintiffs in these lawsuits is that metal-on-metal devices were defectively designed and the manufacturers did not take reasonable steps to test the safety of the devices. Metal-on-metal implants have been proven to be defective because the metal components of the device grind against each other creating metal debris and corroding the device. The metal debris damages the tissue and bone surrounding the implant while the corrosion of the device causes its failure and forces patients to undergo revision surgery. Additionally, manufacturers did not sufficiently test these metal-on-metal devices before distributing them on the market. Manufacturers like Smith & Nephew unreasonably assumed that these devices were “substantially equivalent” to ceramic and plastic devices that had already been tested and distributed on the market. However, these metal-on-metal devices created newer and greater that could have been discovered through reasonable testing.
Recent Smith & Nephew Claims
In recent years, Smith & Nephew has manufactured a number of defective hip and knee replacement systems that have required recalls and led to lawsuits against the company. In 2003, the company recalled two of its knee replacement systems after 26 percent of patients implanted with the device needed revision surgery. Additionally, in 2010, the company recalled 40,000 baseplates. These defective baseplates led patients to file lawsuits because in some cases the device failed only six months after implantation. The company’s most recent recall was in June 2012 after the metal liner of its R3 Acetabular System was determined to have a higher than normal failure rate. This hip replacement system used the dangerous metal-on-metal method. It is likely that this device will lead to many lawsuits against Smith & Nephew in the coming years because between 3,000 and 4,000 Americans have been implanted with the device. Recently, a California man filed a lawsuit against Smith & Nephew after the R3 Acetabular System he was implanted with failed. He was implanted with the device on September 8, 2010 and underwent revision surgery on November 20, 2010 because he began experiencing pain and “hearing a grinding noise” from the implant. His surgeon diagnosed the problem as device failure. The plaintiff now alleges that the R3 Acetabular System causes metallosis, blood toxicity, and premature device failure. If you have experienced side effects such as pain, infection, osteolysis, metallosis, ossification, osteonecrosis, device loosening or failure, fracture or dislocation from a Smith & Nephew hip or knee implant you should contact a personal injury lawyer.
Smith & Nephew About Manufacturer
Smith & Nephew has manufactured hip and knee replacement systems using the dangerous metal ball in metal cup method. Smith & Nephew was founded in 1856. Today, its corporate headquarters is located in London, England, and it also has corporate offices in Andover, Massachusetts and Memphis, Tennessee. Smith & Nephew has grown into a multinational company and is one of the leading medical device manufacturers in the areas of joint products, wound management products, and trauma therapy products. In recent years, the company has acquired multiple competitors across the globe including Oratec for $310 million, Plus Orthopedics for $889 million, and BlueSky for $110 million. Smith & Nephew is the largest medical device manufacturer in Europe and the fourth largest medical device manufacturer in the United States with a 12 percent share of the market. In 2011, the company’s annual revenue was $4.3 billion with $2.3 billion attributable to its sale of joint products such as its hip and knee replacement systems.
Government Reports on Smith & Nephew
In 2007, Smith & Nephew was investigated by the Securities Exchange Commission (SEC) for its violation of the Federal Corrupt Practices Act. Specifically, the company improperly influenced doctors to recommend Smith & Nephew products over other products. Smith & Nephew along with other medical device companies settled these federal claims for $311 million. In 2010, the FDA issued a warning to Smith & Nephew after determining that the company’s manufacturing practices of a R3 Acetabular System component did not meet minimum sterilization requirements.
Smith & Nephew Recalls
In recent years, Smith & Nephew has issued multiple recalls on its joint products.
In 2003, the company recalled its “Genesis II” and “Profix II” knee replacements. 26 percent of patients implanted with the device needed corrective surgery. In 2007, the Smith & Nephew recalled a knee replacement system after a supplier manufactured parts with a higher than specified iron content. In 2010, the company recalled about 40,000 defective tibial baseplates. Recently, in June 2012, Smith & Nephew recalled the metal liner of its R3 Acetabular System after the failure rate of the hip replacement system exceeded the standards created by Great Britain’s National Institute for Health and Clinical Excellence. This metal-on-metal hip replacement caused infections, fractures, and dislocations in patients using the device. Smith & Nephew’s recall is part of a growing number of manufacturer recalls of metal-on-metal implants across the globe.
Smith and Nephew Lawsuits
Today, Smith & Nephew faces a growing liability from its defective joint products. The defective tibial baseplate has led to multiple lawsuits after the device broke within six months of implantation for one plaintiff and within two years of implantation for another plaintiff. Additionally, the R3 Acetabular System has led to a growing number of lawsuits. Specifically, the ceramic liner did not meet sterilization requirements causing infection and the metal liner has a higher than normal failure rate. The metal liner like all metal-on-metal implants is corrosive leading to pain, infection, fracture, and dislocation. Recently, a California man filed a lawsuit against Smith & Nephew alleging that the metal liner caused metallosis. Metallosis is caused by the corrosion of metal-on-metal devices and the resulting build up of metal debris on soft tissue.
PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING USE OF SMITH & NEPHEW OR ANY OTHER PRESCRIPTION MEDICATION.
Have You or a Loved One Experienced Infection, Fracture, or Dislocation From a Smith & Nephew Hip or Knee Replacement System?
If you or a loved one has experienced pain, infection, fracture, or dislocation from a Smith & Nephew hip or knee replacement system, you may want to speak with a lawyer regarding a Smith & Nephew claim. A personal injury attorney familiar with new developments in the investigation of these metal-on-metal implants may be able to help you make important personal and legal decisions. d’Oliveira & Associates, P.C, is working with some of the leading defective medical device lawyers in the country who are handling these cases.
Please contact the law offices of d’Oliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.