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According to The New York Times, an estimated 500,000 individuals have undergone a surgery involving a metal-on-metal hip implant. A quality hip implant is usually expected to last for approximately 15 to 20 years, depending on the patient’s activity level, fitness level and general health.
Many hip replacement patients, however, find that their implants begin to show signs of failure in a matter of a few short years. These patients have begun pursuing legal action against the manufacturers of these defected implants, but they need to first equip themselves with the necessary information before heading to court.
How to Find Out if You Have Been Affected by a Defective Hip Implant
The majority of hip implant patients have become accustomed to chronic pain and stiffness over the course of many years. In fact, these two symptoms are the most commonly cited reasons for the decision to have hip implant surgery in the first place. Unfortunately for many hip implant patients, the familiar pain associated with hip problems before the surgery may never actually improve, particularly if the implant used is defective.
Symptoms of a potentially defective or dangerous hip implant include:
- Noticeable swelling that does not respond to anti-inflammatory medications
- Unusual warmth in the area surrounding the implant
- Difficulty when walking, bending, sitting down or getting up
- Pain and stiffness that do not go away with proper medication and rest
Complications that arise from a defective hip implant may grow to be incredibly serious when not addressed in a timely manner. Corrosion of metal-on-metal components in an implant can allow minute particles of metal into the blood stream and into the tissue at the implant site. Severe cases can lead to tissue death around the implant, dangerously high levels of cobalt and chromium in the blood, and substantial bone loss.
List of Recalled Hip Implants
All hip replacement and hip surgery patients are strongly encouraged to consult their surgeons and medical records to determine what type of device was used during their procedure. Though many surgeons are able to reach their patients with relevant recall information relatively quickly after the information has been made available to them, not all patients are made aware of the potential danger they face. The following is a list of some recalled hip implants over recent years:
- DePuy ASR XL Acetabular Hip System
- DePuy ASR Hip Resurfacing System
- Stryker Orthopaedics Rejuvenate Modular Neck Stem
- Stryker Orthopaedics ABG II Modular Neck Stem
- Smith & Nephew R3 Metal-on-Metal Liner
If you or a loved one have undergone hip surgery and have suffered adverse effects because of the type of implant used, you may be entitled to financial compensation. The statute of limitations for filing a lawsuit concerning defective implants varies from state to state, so quick and decisive action is strongly recommended.
A product injury lawyer is a legal professional with experience in pursuing financial compensation for injuries or death caused by faulty products. Your attorney will help you make the important decisions regarding your case from start to finish, as well as make sure that you are awarded a fair amount of money for your pain, suffering and medical expenses. Don’t allow multi-billion dollar businesses to take advantage of you in your time of need. Even if you have not yet begun to experience side effects associated with your hip implant, it is important to obtain a legal consult immediately in order to ensure that you get the compensation you deserve.
Total hip replacements are performed to treat a variety of conditions affecting the hip joint, including degenerative joint disease, arthritis, congenital hip dysplasia, and physical trauma. Hip ailments are more common in elderly people, but younger people can suffer from these conditions as well. Besides various diseases of the joints, physical trauma usually occurs due to falls, auto accidents, or other acute injuries.
The hip is a ball and socket joint. The hip bone itself has a rounded gap, or socket, which the rounded ball of the femur, or thigh bone, fits into. This type of joint has a lot of flexibility as the joint can swivel in any direction. This is why hips can bend in more directions than knees or elbows, for example. It also makes broken hips particularly difficult to heal, which is why surgical intervention is sometimes necessary to promote mobility.
Types of Hip Implants
- Metal on polyethylene implants. This is the most common type of implant. In this method, both the ball and socket portions of the joint are removed and replaced with a metal prosthesis. A polyethylene spacer is then placed between them. The metal used is usually titanium-aluminum, stainless steel or cobalt-chrome. These implants do wear down over time, so subsequent replacements may be necessary in patients who live a long time post-surgery. A relatively new type of polyethylene is quite popular now due to its strength and durability. These new implants rely on a wear-resistant type of plastic that is manufactured to be stronger than regular polyethylene. Because these implants are new, long-term studies have not been completed to determine whether they will truly wear down more slowly than other types of implants
- Metal on metal implants. These work similarly to the above type, but there is no plastic spacer between the metal elements. This reduces the amount of wear that the artificial hip takes, but it does pose a potential risk to patients due to the release of metal ions into the patient’s bloodstream.
- Ceramic on ceramic implants. These implants use ceramic pieces for the ball and socket portions of the joint. Ceramic is much less prone to wear than metal or plastic, but it can be brittle and prone to breaking.
Regardless of the materials used, the implant will generally be held in place with a special type of medical cement. It may also be wedged into place without cement so that the bone can heal over the implant and hold it in place.
Types of Hip Replacement Procedures
Surgeons utilize a variety of surgical options to address pain experienced by patients suffering from diseases of the hip joints. These options include total hip replacements where an artificial ball, socket, and stem is implanted into the joint to replace the existing diseased or damaged bone. Surgeons may also perform a total hip resurfacing where an artificial ball and socket is implanted, but the stem is very short in length and does not penetrate deep into the femoral bone. A resurfacing procedure is generally less invasive than a total hip replacement. Surgeons may also perform a partial hip replacement, also known as a hemi-arthroplasty, in which only the ball is replaced with an artificial implant. For physical trauma, depending on the extent of an injury, a broken hip can sometimes be healed naturally by limiting a patient’s movement. More serious injuries may require surgical intervention.
A traditional hip replacement surgery requires an incision through either upper thigh or buttocks of the patient. Less-invasive techniques use smaller incisions and specialized instruments to complete the procedure. Regardless of the procedure completed or the materials used, a hip replacement surgery takes time and therapy to recover from. Some complications can arise if the new hip does not form a strong attachment to the existing bone. The patient may also continue to experience pain in the joint long after recovery is over. Fortunately, as technology improves, hip replacement surgeries become more effective.
Stryker is a prominent medical device and orthopedic product manufacturer that supplies hip implants, knee implants and surgical equipment used at major medical centers. Over the past several years, some of Stryker’s products have been recalled due to defects in their design or construction which have resulted in devastating injuries. These defects can make medical products unsafe for their intended use. Under product liability law, a manufacturer is responsible for ensuring that its products meet safety standards and do not pose a threat to consumers. Manufacturers are also responsible for warning patients of the risks associated with their products.
Here are a few of the major lawsuits and recalls that have affected Stryker and unsuspecting consumers across the country.
The Stryker Neptune Waste Management System
Stryker issued an urgent Class I recall for its Neptune series of waste management systems. This recall was issued on June 8, 2012, after the company received reports of serious and fatal injuries. These systems collect fluids during surgery by using a vacuum-like apparatus. When operated at high-pressure, the device can cause serious tissue damage, organ damage and fatal complications. This recall covered all six waste management models in the Neptune series. Stryker is facing a growing number of product liability lawsuits for injuries caused by these dangerous devices. Investigations show that these systems were not approved by the FDA and were not labeled properly.
Stryker Ceramic Hip Recall
In January 2008, Stryker voluntarily recalled its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cup implants. Stryker’s Trident hip implants were recalled due to contamination at a manufacturing plant. These particular ceramic hip implants were prone to premature failure. A number of patients reported embarrassing squeaking and popping noises during normal activities. These issues are related to ceramic fragments, hip fractures and the loosening of components. Patients who were affected by faulty Trident hip implants are still coming forward, and more lawsuits are being filed.
Stryker Metal-on-Metal Hip Implants
On July 6, 2012, Stryker voluntarily recalled its ABG II and Rejuvenate modular neck stems that are used in hip replacement surgeries. The first product liability lawsuit alleging problems with the ABG II and Rejuvenate neck stems was filed on August 7, 2012. An increased risk of corrosion and metal poisoning were cited as the reasons for the recall. Stryker admitted that the systems were prone to wear and tear near the neck junction. These problems may cause pain, swelling and adverse local tissue reactions. If left untreated, these conditions can lead to aseptic loosening and sepsis.
More than 50,000 defective implants were sold before the recall, and people have begun to file suit. These plaintiffs are requesting a case consolidation that would allow patients from Arizona, Florida, Minnesota and New Jersey to move their cases to New Jersey’s Bergen County Superior Court where they will receive individual trials and settlements. This venue was requested due to the proximity to the Stryker headquarters.
Since 2007, Stryker has received several urgent warnings and complaints from the FDA and the U.S. Department of Health and Human Services. These citations were for failing to test problematic devices and for failing to fix the defects. The company also received multiple contamination warnings. Sterile medical implants were allegedly cleaned and packed in unsanitary areas where microbes exceeded allowable levels.
Between 2007 and 2008, Stryker, DePuy, Zimmer, Smith & Nephew and a host of high-profile orthopedic manufacturers were sued by the Department of Health for engaging in unfair sales strategies and offering unlawful kickbacks to surgeons who directed hospitals to purchase their orthopedic implants and other devices. The FDA has noted several serious design flaws and sterilization issues associated with Stryker’s surgical implements and orthopedic implants. Problems with Stryker’s Duracon, Scorpio and EIUS Unicompartmental Knee Implants have lead to more recalls and lawsuits.
Product liability issues are particularly dangerous when medical devices are involved. Due to the implications of defective medical devices, patients can often sue to recover medical expenses and punitive damages. Victims might also be eligible to request compensatory damages for pain, suffering and loss of consortium.
Stryker Orthopaedics Corporation has issued a voluntary recall on its Rejuvenate Modular and ABG II Modular Neck Stems after post-distribution reports were issued stating that these implants are susceptible to corrosion and/or fretting, which can lead to metallosis, adverse local tissue reactions, and pseudotumors.
Arthroplasty, also known as a hip replacement, is the replacement of the diseased or deteriorated hip joints with a prosthesis to relieve pain and increase mobility and function in the hip. The Stryker Rejuvenate system is a device with a stem and neck designed to replace the patient’s hip by providing a mechanism that allows the joint to pivot as it would naturally. The Stryker ABG II Modular Neck Stem is a product designed to reconstruct the hip joint area by attaching inside the femur and coming out to connect with the hip.
Hip Replacement Risk
Standard risk to patients who receive hip replacements include decrease of bone mass or bone loss, nerve damage, uneven leg length, stiffness, and decrease in immune system function. Revision surgery is usually warranted in cases where the patient is experiencing post-surgical issues such as metal sensitivity, loosening of the implant, audible sounds from the area during movement and general wear over time.
When metal pieces in hip implants constantly rub against each other, corrosion occurs. Unlike true metal-on-metal devices where the ball and socket are both made of metal components, both the AGB II and Rejuvenate products had metal stems and metal necks that rub together in a way similar to how the ball and socket devices do.
When corrosion or fretting occurs in metal hip implants made with cobalt and chromium metals, such as the Stryker Rejuvenate Modular and ABG II Modular Neck Stems, the patient can develop metallosis, a condition where metal debris collects in the soft tissues. This can cause inflammation and swelling, as well as destroy the otherwise healthy tissue surrounding the implant site. With deterioration of the tissue, the implant may become misaligned, causing severe pain, infection, swelling, and dislocations These complications can eventually necessitate a revision surgery.
While hip replacements are designed to withstand up to fifteen years of use, both the ABG II and Rejuvenate replacements began showing signs of failure after several months. This caused excessive post-surgical pain that required revision surgery in some patients.
If metallosis exists, inflammation and swelling of the area around the implant could occur, with some cases of pseudotumors and fluid in the joint. Tissue damage from metallosis can present as a rash in the affected area. An often overlooked sign of metallosis is extreme pain, which many patients dismiss as after-effects of the replacement. Metallosis can also cause the levels of cobalt and chromium metals in your blood to elevate. In some cases, this elevation of metal levels can be toxic and cause many systemic illnesses.
Further side-effects of metallosis include the following:
- Recurring infections
- Gastrointestinal issues
- Emotional imbalance
Patients who have either the Rejuvenate Modular or ABG II Modular Neck Stems should contact their doctor immediately. While not every patient who received Stryker’s ABG II or Rejuvenate products have experienced symptoms of metallosis or product failure, all ABG II or Rejuvenate recipients should contact their doctor.
Fresenius Medical Care, the German-based company responsible for treating over one third of American dialysis patients, is under scrutiny after information came to light linking their dialysis products GranuFlo and NaturaLyte to an increased risk of cardiac arrest. More troubling than the up to six-fold increase in risk of cardiac arrest over competing products is that Fresenius appears to have hid the information from the public, as evidenced by an internal memo that was released in November 2011. The memo, titled “Dialysate Bicarbonate, Alkalosis and Patient Safety,” was distributed to doctors operating in Fresenius-owned medical care centers in the United States, and warned that their products could be linked to an increased risk of patients dying through sudden cardiac arrest. It wasn’t until the memo was anonymously leaked in March of 2012 that the problem became public knowledge.
Of particular import in a case such as this are the dates in which the situation unfolded, e.g., there was over a four months between the date of the initial memo and the release of the leaked version. Therefore, to help make the case clearer, we have outlined the most crucial developments in the case in the timeline below.
January 1st – December 31st, 2010 – First Information Concerning Risks Emerges
Research carried out by Fresenius Medical Care (FMC) discovers that 941 patients from 667 facilities suffered from cardiopulmonary arrest. This figure is over six times higher than that of competing products.
September 15th, 2011 – FDA Sends Warning Letter to Fresenius
The FDA sends a warning letter to the Fresenius CEO after their investigation reveals FMC is inadequately addressing complaints filed by patients using the company’s products. The letter addresses five major areas of fault, including “Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate” and “Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems.”
November 4th, 2011 – Internal Memo Circulated
The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with their GranuFlo and NaturaLyte products. In the document it is written that “[the] issue needs to be addressed urgently.”
March, 2012 – Memo is Leaked to the FDA
Over four months after the original internal memo was circulated, the memo is anonymously leaked to the Food and Drug Administration (FDA).
March 29th, 2012 – Fresenius Issues Warning to Doctors
On March 29th, 2012, Fresenius releases a modified update to the original memo, warning doctors of the dangers associated with its products. The same day, the FDA issues a statement informing the public of the notice. In the statement, the FDA writes, “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate…This product may cause serious adverse health consequences, including death.” The recall is listed as “voluntary.”
May 25th, 2012 – FDA Issues Update Warning Doctors of Dosing Dangers
The FDA releases an update warning doctors of “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” The press release recommends that doctors exercise more caution when prescribing these products to patients and urges doctors to “be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels greater than or equal to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
June 14th, 2012 – New York Times Reports that FDA is Investigating Fresenius Medical Care
An article released on June 14th raises the public profile of the Fresenius case by reporting that the FDA is investigating the company to determine if Fresenius “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.” The report gives a brief summary of the case until that date, and includes a statement from Steven Silverman, the director of compliance for the FDA’s medical device division, in which he states, “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”
June 27thth, 2012 – FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products
FDA releases a statement announcing a Class I recall of GranuFlo and NaturaLyte, citing that “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” Class I recalls are the most serious recalls of their kind and the move is considered one of the most important developments in the ongoing case against Fresenius.
For more information, visit www.seegerweiss.com/granuflo-lawsuit.
For some patients, the recent hip implant recall by Stryker Orthopaedics will lead to revision hip surgery. Hip revision surgery will unfortunately be needed to replace their faulty Rejuvenate or ABG II module implants. This is truly unfortunate because the typical lifespan of a well-functioning artificial hip joint is 10-15 years and revision surgery brings a lengthier and riskier procedure, as well as greater uncertainty of its outcome.
Few Options Available for Patients
The most pressing and problematic issues with the Stryker recall devices center on its fretting and corrosion, which may lead to metallosis, a serious condition from metal debris leaking into a patient’s bloodstream, the loosening of the implant causing grave pain and discomfort, and the inflammation and damage to surrounding bone and tissue. All of these conditions may warrant a hip revision surgery and bring forth new complications that the patient and surgeon need to consider, for example:
- Quality of patient’s bone and the ability to securely fit revision hip replacement into position
- Higher chance of hip dislocation after surgery due to weaker tissue surrounding the bone as well as more fragile bone
- Lengthier surgery by having to remove old implant and securely placing new one
- Longer rehabilitation timeframe
- Possibility of smaller range of motion
- New prosthesis won’t last as long (eight to 10 years vs. 10-15 years)
If your physician is recommending hip revision surgery because of the Stryker recall and its inherent problems, contact us as soon as possible. Legal options may be available.
For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-recall.
Stryker Manufacturing Practices Questioned
Concerns about Stryker Orthopaedics hip replacement products began in 2005, two years after the Trident Acetabular Cup System, a hip implant system, was approved and released to the market. Patients started complaining about the squeaking noises of their Stryker hip replacements and the improper seating of their hip replacements causing bone fractures, so the FDA took action. After inspecting the Stryker Ireland manufacturing plant and finding a lack of conformity with Current Good Manufacturing Practice (CGMP), the FDA issued a warning letter to the company on March 15, 2007. The warning said the facility was failing to establish and maintain adequate procedures for fixing products and analyzing risks.
A second warning was issued by the FDA on November 28, 2007, following another inspection—this time of the company’s New Jersey plant. Once more, the FDA brought attention to the fact that the company had failed to establish procedures for identifying and correcting nonconforming products and addressing other quality problems.
For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-recall.
Following a string of troubling findings concerning the risks involved with the use of GranuFlo and NaturaLyte dialysis products, Seeger Weiss LLP is advising that the Food & Drug Administration (FDA) has opened up an inquiry into the parent company Fresenius Medical Care (FMC), combined with a Class I recall of both products. The inquiry’s goal is to determine whether Fresenius violated federal regulations by omitting critical information concerning the potentially deadly risk associated with use of the products.
FMC, based in Germany, is the largest operator of hemodialysis centers in the United States, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year. A memo that Fresenius issued in November of 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems.
The issue was first brought to public attention after an internal memo was anonymously leaked to the FDA earlier this year. In the memo dated November 4th, 2011, FMC warned doctors operating in their dialysis centers that their products may be causing dangerously high biocarbonate levels that would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products. The memo also stressed that “This issue needs to be addressed urgently.”
Despite the findings, it was only after the FDA opened an investigation into the matter that FMC issued a wider warning to other care centers, which it did in March of this year. In June, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products from Fresenius.
As more information becomes public, patients who have suffered injuries are seeking redress and exploring their legal options. Chris Seeger, one of the partners of the law firm Seeger Weiss LLP, said that the decision Fresenius made not to inform the public of potential dangers reflects a failing on behalf of the company. “By not advising the FDA, the medical community and dialysis patients as soon as possible about the dangers of GranuFlo and NaturaLyte, Fresenius made the decision to put profits ahead of patient safety. They aren’t the first pharmaceutical company to make that decision and, unfortunately, they won’t be the last.”
Additionally, Mr. Seeger says that the error is made all the more egregious due to the fact that much of the damage to patients was preventable if Fresenius had responded quickly and efficiently to initial reports of the problem. “You would not expect a company that makes millions of dollars a year from dialysis patients to knowingly put those patients at risk for serious injuries, including death, but that’s exactly what Fresenius did. Fresenius was in position to prevent these injuries but chose not to do so. They must be held accountable.”
Seeger Weiss LLP is offering free consultations to those that might have been affected by the products. If you suspect that you or someone you know has been injured after using GranuFlo and NaturaLyte products in dialysis, contact Seeger Weiss by visiting http://www.seegerweiss.com/ or by calling directly at 888.584.0411.
Donald Foster III, a former dialysis equipment manager at Fresenius Medical Care (FMC), has been charged with attempted murder and burglary after allegedly pouring bleach into the dialysis machines at a South Carolina clinic. A judge has set his bond at $525,000.
According to Lexington County Sherrif James Metts, Foster had been suspended from his position on July 2 at FMC for providing prescription painkillers to patients. Five days later, Foster returned to pour bleach into the dialysis holding tanks despite being told to stay of the property. Metts suspects that Foster’s motive was seeking revenge against FMC for his suspension.
Fortunately, this potentially fatal plot was foiled by workers at the clinic who noticed a high level of chlorine before the machines were used on the 20 patients scheduled for dialysis treatment that day.
According to Metts, Donald Foster had full knowledge and intent to harm or kill these clients and that he knew the lethal effect of bleach in dialysis treatment. “Thank goodness, his plan failed due to the fact the technicians, even though they had checked the water on Saturday afternoon after they finished all of their clients for the day and took no clients on Sunday and was going to begin back on Monday, they went through their checks and found the high contamination of the chlorine bleach in the water,” Metts said.
FMC has also been in the news recently for unrelated issues with their dialysis products, GranuFlo® and NaturaLyte®, which have been discovered to potentially cause metabolic alkalosis – a significant risk associated with low blood pressure, cardiac arrhythmia, cardiopulmonary arrest, and even death. The FDA has issued a Class I recall of these products, the most urgent recall option, after an FMC memo describing the risks was leaked anonymously.
Noticing an absence of any support groups or forums online for patients who have suffered from the dialysis drugs NaturaLyte® and GranuFlo® , we have decided to create a forum here for dialysis patients to voice there concerns and complaints in a supportive environment.
On March 29th of 2012, the FDA issued a recall of the NaturaLyte® and GranuFlo® dialysis products made by Fresenius Medical Care (FMC). This occurred after an earlier FMC internal memo warning of the dangers of these drugs was disseminated to FMC’s clinics, but not other clinics that also used these drugs. Research show that these drugs cause an elevated risk of cardiopulmonary arrest, metabolic askalosis, hypotension, heart problems, stroke, and even death. Today FMC continues to aggressively market GranuFlo and NaturaLyte despite the FDA’s class I recall.
We hope that this forum will be helpful to people who have been injured by these drugs, and we will also be enlisting the support of medical and legal experts to answer any questions beyond our scope that might arise here.
For more information, visit our GranuFlo information resource page or call us directly at 888.584.0411.