Replacement

Stryker and metal hip replacement issues and information.

Death During or Following Hip Revision Surgery

When people die on the Operating TablePatients Dying During A Hip Revision Procedure

Every year, thousands of individuals suffering from limited mobility undergo hip replacement surgery to improve the quality of their life and eliminate pain in their hip. Unfortunately, not every hip replacement surgery is successful. Often times, significant issues arise where there is an immediate need for revision surgery. The existing device is replaced with a secondary implant after a lengthy and complex procedure. Unfortunately, some patients die during the hip revision surgery as a result of complications, or in the months or years that follow.

Usually, patients elect to have hip replacement surgery as a way to decrease their pain and increase mobility. The diseased or damaged bone and associated tissue is replaced with an artificial implant. The need for hip replacements has never been greater, as more Americans live longer than ever before with highly active lives. The recipient of the hip replacement device is often an individual who has endured sports injuries, or significant trauma to their hip joint.

Over the last few years, hip replacement system manufacturers, including Stryker, have entered the medical marketplace with their own devices using proprietary materials and the unique design. Devices including the ABG II and Rejuvenate were marketed as effective solutions for active individuals in need of a new hip joint.

As the products were brought to market at the end of 2009, Stryker introduced the Rejuvenate hip implant system for individuals needing increase flexibility. The design of the implant allowed the device to be custom-fitted to meet the needs of each individual patient.

Using patented materials and a new design, Stryker manufactured the ABG II and Rejuvenate modular hip implants using ceramic bearing surfaces. The company made claims that the implant posed no potential risk of causing harm associated with common metal on metal surfaces used by their competitors.

Unfortunately, all claims of no associated risks with both devices were untrue. In fact, many patients with the implant are suffering with the same risks as other competitors’ faulty devices. As a result, the company voluntarily recalled both products from the marketplace in July 2012. Patients have experienced numerous medical conditions from the implants, which are outlined in the many formal complaints about the devices, including:

  • Bone fractures
  • High toxicity from metal poisoning
  • Significant soft tissue inflammation
  • Loss of muscle mass
  • Collecting fluid and pseudo-tumors around the implant
  • Extreme swelling and pain associated with the device

The Need for Revision Surgery Even In Patients With Poor Health

Because of the thousands of cases involving significant problems with the Stryker hip replacement systems, many doctors are recommending revision surgery. In a follow-up re-operation, the surgeon removes and replaces the defective device. Unfortunately, the follow-up surgery is significantly more traumatic than the initial procedure, and many patients experience a broken femur bone when the surgeon removes the femoral stem from the leg.

Increased Death Rates During and Following a Hip Replacement Procedure

Typically, hip revision surgeries tend to produce less favorable outcomes when compared to the initial implant operation. Many times, the second surgery requires an extensive amount of hospital stay and recovery time as a result of the lengthy, complex procedure. Most patients require an assistive device including a walker or cane temporarily or permanently after the second surgery.

In addition, individuals that have suffered serious problems from the initial surgery, often experience increased death rates from uncontrollable infection at the replacement site. The devices made by Stryker, and other orthopedic hip replacement system manufacturers, are also known to fail due to corrosion and fretting of the material, especially devices fabricated out of chromium and cobalt metals. The corrosion usually releases metal debris into the bloodstream and surrounding tissue, often compromising the health of the patient.

Taking Legal Steps When A Loved One is Lost Following a Hip Revision

Nearly every patient that has been negatively affected by their Stryker Rejuvenate or ABG II hip replacement device likely feels overwhelmed with what to do next. In all likelihood, the doctor informed you of the recall of your implant, and discussed symptoms and signs of pain, swelling, infection, metal toxicity and other conditions.

The next step is to seek out legal advice on how to proceed with the Stryker hip replacement injury case. Today, thousands of individuals have already filed lawsuits against Stryker and other hip implant manufacturers, as a way to seek legal remedy and financial compensation to cover the extensive costs involved in restoring their health.

If a loved one has died as a result of complications involving hip revision surgery, it is essential to speak with an experienced personal injury attorney that specializes in hip implant recalls. Filing a wrongful death claim against the responsible party holds the company accountable for your losses, pain and suffering, as a surviving family member. Learn more about your legal rights without cost or obligation by completing the contact form here.

Stryker Hip Revision Surgery: Deep Vein Thrombosis (DVT) Related Issues

DVT and hip surgeryPostoperative deep vein thrombosis (DVT) can be a significant problem after a Stryker hip revision surgery, leading to lethal complications. Many times, DVT is challenging to diagnose because classic clinical symptoms and signs are not always present. If the doctor is not suspicious or curious of obvious lacking signs, the individual can develop significantly serious problems, which could lead to death.

In 2009, the Stryker orthopedic medical device company began marketing its Rejuvenate and ABG II modular hip replacement systems. Originally, the hip implants were thought to be far superior to traditional metal-on-metal hip replacement devices. Unfortunately, by July 2012, Stryker voluntarily recalled their hip replacement systems due to significant issues including injury and death related to DVT and other medical problems.

As a result of the failed system, thousands of individuals underwent Stryker hip revision surgery, where the original implant was removed and replaced with new components. Unfortunately, revision surgery is significantly more complicated than the original procedure, taking up to six months to fully recover. Due to the extensive recovery time and challenging rehabilitation, many patients develop a variety of complications including deep vein thrombosis.

Complications from A Hip Revision Surgery

Once the revision surgery is complete, doctors often prescribe therapies and medicines in an effort to prevent blood clots from forming. The medication is often prescribed as a way to minimize the potential of developing DVT that can occur during and after surgery. Patients are often advised to wear special compression embolism stockings and perform ankle pumps in the first three days after the revision procedure. In addition, physiotherapists, doctors and nurses will likely insist that the patient begin using the legs as quickly as possible once the operation is complete.

Additionally, doctors will prescribe PCA (patient-controlled analgesia) allowing the patient to control the amount of supplied pain medication through an IV during the first few days after surgery. These medications include dabigateran and rivaroxaban. However, it is often after the patient is release from doctors’ care that significant deep vein thrombosis can occur, due to inconsistent monitoring to detect symptoms. Common symptoms of DVT include:

  • Swelling or pain at the revision surgery site
  • Increased redness
  • Incision drainage
  • Pimples or bumps

If a blood clot migrates from the legs to the lungs or brain, it can cause instant death. Usually, DVT problems occur within the first few weeks after the operation. Any patient experiencing issues including swelling and pain in the associated hip or leg should seek medical care immediately. Doctors often prescribe anticoagulant medications as a way to reduce the potential of clotting. However, the medication often increases the risks of bleeding at the incision site.

Many medical experts note that hip revision surgeries tend to have increased risks with associated complications along with a reduced chance of success when compared to the original procedure. In addition, deep vein thrombosis can also occur in individuals that choose to avoid Stryker hip revision surgery. Often times, these individuals experience increased swelling and pain, which can leave the patient to a prolonged hospital stay until the medical condition has been controlled adequately.

Extensive Physiotherapy Exercises

One of the main factors leading to deep vein thrombosis as a direct result of Stryker hip revision surgery is a lack of performing physiotherapy exercises. Physiotherapists usually recommend performing these exercises once every day at a minimum. The exercises are designed to assist in recovery by restoring lost strength and movement in the hip. Without proper exercising, the diminished physical activity can cause significant problems including DVT.

Seeking Legal Assistance In The Event of DVT or Other Medical Complications

In an instant, any blood clot forming in the calf muscles can easily travel throughout the body in settle in the lungs (pulmonary embolism) or in the brain (cerebral embolism). Patients suffering from DVT complications or other medical issues caused by a hip replacement device should seek legal assistance to file a claim. The costs involved in undergoing revision surgery can be extensive and require adequate compensation to pay off mounting medical bills, recoup lost wages, and provide recompense for pain and suffering.

Stryker, and other orthopedic hip replacement device manufacturers, can be held legally liable for complications associated with their implants. Many patients requiring revision surgery are exposed to significant risks, especially after the second and third procedures. In fact, recurrence of any previous complication is always an issue, such as metallosis (metal toxicity), femur bone fracture, myositis ossification (improper bone growth) and thrombophlebitis (DVT).

Determining the next step should only be taken using legal advice. Thousands of individuals across the United States have already filed lawsuits against Stryker, Biomet, Zimmer Durom, DePuy and others to receive the financial compensation they deserve.

Infections Associated With Femur Fractures When A Stryker Device Is Removed

Femur Fracture InfectionsAn infection caused by a femur fracture is one of the leading devastating complications resulting in hip revision surgery. A periprosthetic fracture on the patient’s femur can occur by accident during revision surgery when attempting to remove the implant for replacement. However, the surgeon often has no other alternative but to purposely fracture the patient’s femur during surgery to remove the implant stem.

An infection within the hip joint and/or stem often leads to the need for revision surgery as a correction for numerous reasons, which might include:

  • Extensive pain in the patient to join
  • Hip injury
  • Hip joint instability
  • Loosening of the hip implant in the femur bone
  • Osteolysis (bone loss)
  • Deteriorating hip replacement device causing metallosis (metal toxicity)

Causes of Hip Replacement Failure

While there are numerous reasons a hip replacement device can fail, deteriorating components represent a high majority of hip revision surgeries. Artificial hip manufacturers, including Stryker, have recalled a variety of orthopedic medical devices including the ABG II and the Rejuvenate modular neck hip systems. This is because most are fabricated with proprietary metal alloys that can corrode, fret and fail over time, causing a variety of problems including infection.

Experts have long touted hip arthroplasty (replacement surgery) as an innovative solution for millions of individuals suffering hip pain from arthritis and other medical conditions. However, replacing a hip with Stryker and other manufacturers’ implants has associated complications and risks.

Hip Replacements for Younger Individuals

Historically, doctors have implanted hip replacement systems in older patients who tend to be less active or suffering from severe cases of arthritis. However in recent years, Stryker, the New Jersey-based prosthetic device manufacturer, marketed their Rejuvenate hip replacement system to younger more active individuals to improve their flexibility and mobility.

Unfortunately, many Stryker hip replacement device failures were reported within months after making it available to the public. By July 2012, the company voluntarily recalled its hip replacement device systems, starting a cavalcade of lawsuits aimed at compensating injured victims for their pain, suffering, damages and loss of quality living.

Hip Implant Particle Debris

Many of the first reported signs of failure indicated deterioration of the hip replacement metal surfaces. Friction caused by two components rubbing together (the hip ball and cup) caused abrasive wear and produced free-floating debris. Often times, the loose debris irritates and inflames the surrounding tissue while causing infection to the area.

Some patients who have undergone an initial Stryker hip replacement surgery have experienced acute (temporary) infection in the joint area. Unfortunately, many patients with Stryker hip devices experience chronic (permanent) infection that developed in both the early and late stages after the implant surgery. Depending on the infection’s location, it can be superficial and easy to treat, or deep in the leg and nearly impossible to treat using pulsatile lavage or debidement.

Often times, the device needs to be replaced to prevent further growth and colonization of the bacteria. If the bacterial infection occurs deep in the leg during the late stages after surgery, it is often unlikely to completely eradicate the infection while attempting to preserve the hip implant. Because of that, physicians often recommend revision surgery, to remove the existing implant and replace it.

Infections caused by a Stryker implant device can be either a bacterial or fungal pathogen. Depending on the causative bacterium, the course for treatment is often complicated and prolonged, even after revision surgery. Though rare, a fungal infection is often persistent and complicated. It is usually found in patients suffering from suppressed immune systems. Unfortunately, any local anti-fungal therapy will likely not produce optimal results, and instead require revision therapy.

Often times, the patient is required to have the implant removed and replaced with a temporary “spacer.” This will allow time for the body to heal the infection before a new replacement hip is implanted weeks or months after the first revision surgery. In extreme cases, where no treatment plans can control the infection, the leg and entire hip might need to be amputated.

Taking Legal Action After Complications Associated With Hip Implant Removal

The cost involved in managing an infection through proven treatments with follow-up hip implant revision surgery is expensive. Because of that, many victims that were implanted with a Stryker hip replacement system are taking legal action for financial compensation to recoup their damages, losses, pain and suffering.

Victims suffering infections from their hip replacement implant are holding Stryker accountable for their actions of designing, manufacturing and distributing defective hip replacement systems that have failed. Thousands of lawsuits over the Stryker ABG II and Rejuvenate hip implants have already been filed, with action pending in appropriate federal courts across the nation.

What to Expect Before & After a Stryker Hip Revision Surgery

Expectations prior and post hip revision surgeryPatients who experience a corrosion of components in Stryker hip implants may need to receive a revision surgery. As Stryker components become worn, they can release metal debris into the bloodstream. The release of metal debris can then trigger conditions like metallosis (see here) and adverse tissue reaction. If patients experience pain and swelling, these can be indicators of adverse tissue reaction. Patients who have these symptoms should speak with a physician about their options and whether they may require a revision surgery.

Diagnosing Issues Related to Stryker Hip Implants

Those who have Stryker hip implants may wish to speak with a medical professional about any issues related to the implant. Ever since Stryker Orthopaedics initiated a voluntary recall of the Rejuvenate and ABG II systems in 2012, thousands of patients have experienced pain, swelling, infection and other serious health issues as a result of defects in the Stryker hip implants.

People who experience a loss of mobility or cannot place weight on a hip may require a revision surgery (learn more about these procedures here). A patient may feel pain in an area in which a hip implant component has loosened. Prior to any hip revision surgery, a physician will conduct a diagnosis to detect the exact causes of pain in the patient. He or she will study the movement of the components in the hip region and detect whether corrosion has impacted the hip implant. The physician can also determine whether a patient has developed an infection, and this may require an immediate revision surgery. Symptoms of an infection include swelling, redness, itching and extreme pain. A revision surgery may be required for patients who have deep infections.

Symptoms Leading to a Stryker Hip Revision Surgery

A patient may experience other symptoms or conditions that indicate a revision surgery may be necessary. These symptoms and conditions include:

  • Dislodged neck component
  • Broken stem
  • Dislocated bone
  • Severe swelling or infection
  • Metal poisoning

Preparation for Hip Revision Surgery

Prior to the hip revision surgery, a physician will need to prepare a patient. Preoperative preparation may include determining any health conditions that can be contraindications for hip revision surgery. These conditions may include a mental disorder, depression, cancer or other terminal illness, infection, obesity and paralysis. The physician will also prepare X-rays and diagnostic images to review before the operation. If a patient has a dislodged bone or other unusual condition, then special procedures may be required for his or her treatment. A patient who has severe bone loss may not be an eligible candidate for a hip revision surgery.

Procedure Involved in Hip Revision Surgery

During the operation, a physician will remove the old hip implant. The physician cleans and sanitizes the hip socket. He or she then places a new shell in the acetabulum. The actual revision of the hip implant is the most difficult and arduous part of the surgery. This part entails cutting apart the hip bone and then cementing a new implant into the femur. If a patient has weak bones, a physician may need to implant bone grafts to strengthen the new structure.

Physicians may also use a ballistic chisel technique to remove old cement pieces. The chisel can be used to crack old cement and loosen a defective hip implant. The physician then implants the new femoral component and stitches up the incision.

Risks Associated with Hip Revision Surgery

Every patient should be informed of the serious risks associated with a hip revision surgery. Research studies have indicated that risk factors may affect certain demographics. For example, African American patients frequently have more complications than Asian Americans or Caucasians. Men also struggle with recovering from a hip revision more often than women. Some of the other risks associated with hip revision surgery include:

  • Risk of death
  • Development of infection
  • Dislocation
  • Need for additional revision surgeries
  • Adverse tissue reaction
  • Pseudotumors

Aftercare: Recovering From a Hip Revision Procedure

After a hip revision surgery, physicians may suggest that patients use a walker, cane or wheelchair to move around for a few weeks. Patients may also need to permanently use a walker depending on the pain that they experience after a revision surgery. Doctors may prescribe pain-killers for patients after a revision surgery and may also provide instructions for cleaning the wound area.

Demographics Of People Requiring A Stryker Hip Revision Surgery. Who Are They?

Different People Who are getting Stryker HipsAdverse Local Tissue Reaction in Hip Revision Surgery Patients

A recent research study completed by H. John Cooper and his associates revealed that individuals between the ages of 43 to 77 were at risk for developing metal poisoning and significant on-set pain after a revision surgery involving metal hip replacement devices. The study is entitled, “Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual-Taper Stem with a Cobalt-Chromium Modular Neck” and has been published by the Journal of Bone and Joint Surgery.

The study shows that immediately following the corrosion of metal hip replacement devices, patients reported experiencing chronic pain for a total of 8.6 months before receiving a diagnosis and revision surgery. When the revision surgery was finally performed, the pain did not stop for patients who underwent the invasive procedure. Instead, some patients suffered from worsened conditions, such as additional fractures, during or after a surgery. Other patients had hips that required an extensive trochanteric osteotomy procedure to remove a hip implant. The results of the research study also indicated increased levels of cobalt, chromium and titanium in men and women between the ages of 43 and 77 who had received revision surgeries after the corrosion of their metal hip replacement devices. These increased metal levels indicate that patients may already be experiencing forms of metal poisoning.

Pain Following Revision Surgeries with Hip Replacement Devices

Out of all 12 patients involved in the research study, every patient suffered from localized pain in the groin area following his or her revision surgery. A 61-year-old female patient also reported other symptoms, including limping, weakness and swelling. Three other female patients between the ages of 43 and 46 also reported a limp in addition to the groin pain that they suffered in following a revision surgery with a metal hip replacement devise.

Experience of Pain in Male Patients

The male patients involved in this research study were between the ages of 63 and 65. These male patients suffered from pain in the groin area, and one male patient also reported experiencing pain in the trochanteric area. The average male patient endured chronic pain for a total of 14.3 months before receiving his revision surgery. In addition, one male patient indicated an extremely high level of cobalt in his bloodstream at a level of 8.9 which compared to the average mean of 6.0. This indicates that corrosion may have caused a severe form of metal poisoning in this male patient.

Experience of Pain in Female Patients

The female patients involved in this research study were between the ages of 61 and 77. On average, female patients reported the experience of pain in other areas of the body in addition to the groin area. The female patients reported the experience of pain in the thigh and buttock area as a result of corrosion of metal hip replacement devices. One 77-year-old female patient experienced pain in the groin, buttock and thigh area for a total of 23 months before her revision surgery was ever completed. Another female patient experienced pain in the groin area, in addition to weakness and swelling, for a total of 20.7 months before her revision surgery was completed.

What the Numbers Mean for People With Existing Stryker Hips

The research study shows that both elderly and middle-aged patients are at risk for suffering from chronic pain before a revision surgery to correct corrosion due to Stryker hip replacement devices. Patients as young as 43 suffered from severe pain for many months prior to their revision surgeries, as indicated by the results of the study. If any patient has suffered from chronic pain and the high costs associated with receiving a revision surgery for a metal hip replacement, he or she can get in touch with a Stryker recall lawyer for additional help. An attorney with experience litigating hip recall cases can help metal hip replacement patients understand their legal rights before and after a Stryker hip revision surgery is completed.

Resources:

Metal Poisoning In Stryker Hip Patients: Significance Of Cobalt, Chromium & Titanium Levels

Metal Poisoning in the Stryker HipThe Risk of Metal Poisoning in Stryker Hip Patients: Development of High Cobalt Levels

In an unsettling report recently published in the Journal of Bone and Joint Surgery, medical researchers discovered that disproportionate levels of cobalt placed Stryker hip patients at a severe risk of developing harmful disorders like metal poisoning. The research study was conducted by H. John Cooper and his associates at the Rush University Medical Center, Northwestern University Feinberg School of Medicine and Indiana University School of Medicine.

The research study tracked 11 patients who had recently undergone revision surgery after suffering from hip replacement issues, and high levels of cobalt were discovered in the bloodstream of these patients. According to the study, the average cobalt levels discovered in patients was 6.0, and the study results indicate that patients with revision surgeries had levels as high as 8.8, 8.9 and 9.5 in cobalt levels after the surgery’s completion.

Screening for Metal Poisoning After Revision Surgeries

The research study also indicated that patients may be at risk for experiencing severe pain after revision surgeries involving hip replacements. The authors of the study recommend that hip patients undergoing revision surgeries have an infection workup and also obtain a serologic screen to discover any high levels of metal in the bloodstream. Patients should also be concerned about joint aspiration. A joint aspiration involves withdrawing a small amount of fluid, and medical professionals can then analyze this fluid to detect the presence of metal or other suspected diseases.

On-Set Pain Following Revision Surgeries with Metal Hip Replacements

Dr. Cooper and his associates also concluded from the study that corrosion at the modular neck-body junction with a modular cobalt-chromium-alloy femoral neck can directly lead to the release of metal ions in the body. This essentially means that individuals with Stryker hip replacements may have already been at risk for suffering from metal poisoning due to the corrosion of the metal components of the equipment. Dr. Cooper and his associates also found that the 11 patients who experienced adverse local tissue reactions from their revision surgeries to correct the corrosion of metal hip replacements were likely to suffer from significant pain following the surgery.

Other Increased Metal Levels in Patients with Revision Surgeries

The 11 patients who required revision surgeries following corrosion of hip replacement devices also experienced a surge in other levels of metal in the bloodstream. The research study indicates that one 65-year old male patient had a level of titanium in his bloodstream of 5.8, and this deviated more than two points from the standard mean. Another 66-year old female patient showed a presence of titanium that was 4.9, which was also significantly over the standard mean of 3.4.

High Cost of Revision Surgeries and Seeking Legal Help

Revision surgeries are costly for patients, and they can also result in intense pain and suffering. The patients in this study have suffered from chronic pain and metal poisoning as a result of their revision surgeries. If you have also suffered from pain and metal poisoning following a metal hip replacement, then a Stryker hip recall attorney can help you understand your legal rights and assist you in getting compensation for your injuries.

Resources:

Consolidation Of Stryker Lawsuit Cases

Stryker Corporation, makers of the Stryker Rejuvenate and ABG II hip replacements that were recalled in 2012, is the next company to be part of multi district litigation (MDL) for the lawsuits related to their hip recall. The New Jersey Superior Court considered the application for MDL in January 2013 and then began forming the committees and pre-trial stipulations to consolidate the recall cases in Bergen County, NJ. This is following in the footsteps of the DePuy recall, which is also a MDL in Bergen County.

How Does MDL Work?

Multi district litigation (MDL) was formed by Congress in 1968 to handle complex civil lawsuits that are filed in several districts, consolidating them in one court. Most MDL involve lawsuits that affect many people, such as medication and medical device recalls. Once a MDL has been assigned to a product recall such as Stryker’s hip replacements, all cases related to the recall are first directed through a centralized court to go through the pre-trial and discovery process. If the case is not settled or dismissed during the MDL stage, then it would continue to trial in the original court in which it was filed.

The MDL system involves assigning one judge to the case in one jurisdiction. There are benefits to having all similar cases held in place, with one judge.

  • Reduced court costs. By consolidating cases for pretrial and discovery, both sides in the civil suit save money.
  • Reduction of court resources. In addition to saving money, MDL saves on court resources by having only one court handling the proceeding versus hundreds. Instead of having many judges having to familiarize themselves with the issue, the assigned judge will be well informed and an expert on the case.
  • Consistency. By having only one judge to issue rulings, all cases will be handled in the same manner with the same stipulations. This creates fairness that all cases are being given the same treatment in the pre-trial stage. In complex cases such as those involving the hip implant recalls, it is important to ensure that there is consistency both in witness testimony, facts and the judge’s rulings.

Stryker Recall Lawsuits

The benefit to those who are pursuing a Stryker hip recall lawsuit is that the pretrial and discovery phase can be quicker and result in either a settlement or progressing on to trial. The MDL saves time and money for the attorneys handling the case by pooling information and resources, allowing them to focus more time on the litigation portion for their clients. The MDL process can speed the beginning phase of a civil trial and get the victim closer to resolution. In most cases, MDL is a benefit to those who are pursuing these large and complex types of civil lawsuits.

http://www.classactionlitigation.com/mdl/faq.html

http://www.judiciary.state.nj.us/notices/2013/n130130a.pdf

http://www.nolo.com/legal-encyclopedia/multidistrict-litigation-mdl-drug-lawsuits-32952.html

Did Stryker Delay in Recalling Its Hip Implants?

Stryker’s hip implants, the Stryker Rejuvenate and the ABG II, are supposed to last between 15 and 20 years. Instead, many patients are finding that they’re having problems after just two years– or less of service. In fact, some patients are experiencing pain, dislocation and other complications just weeks after the surgery.

Stryker’s first hip implant, the Stryker Rejuvenate, was first distributed in February, 2010. They issued their recall on July 6, 2012.

The question is:

Did Stryker delay in issuing the recall?

Did they ignore mounting evidence that their products might be causing harm?

Has their hesitance to take action caused undue pain and suffering to patients?

The Evidence Against Stryker

Complaints against Stryker’s hip products began almost immediately after the product first hit the market. Dianne Pingel is the first person to bring a lawsuit against Stryker. She experienced pain in her hip just three months after the surgery. Doctors performed X-Rays and other diagnostic scans, but were unable to locate the source of her pain.

It wasn’t until they did a blood test that they discovered heavy metal in Pingle’s bloodstream. The hip replacement implant was removed, but Dianne Pingle will likely have to remain under medical supervision for the rest of her life.

Dianne Pingle’s story is not unique. Between the release of Stryker Rejuvenate and its recall, more than 60 complaints have been filed with the FDA around Stryker’s implants. Eight lawsuits have been filed against Stryker as of September 13, 2012. Because of the volume of lawsuits that the courts are expecting, a new multi-district litigation (MDL) case is likely to be opened.

The Condemning Study Against Metal on Metal Implants

In March of 2012, the University of Bristol and the National Joint Registry of England and Wales published a paper condemning metal on metal hip implants. They studied eight years of data from almost half a million patients who’ve received total hip replacement surgery.

The study found that metal on metal hip implants failed three times more often than hip implants made of ceramic, plastics or other materials.

With so much data in the study, the results were clearly statistically significant. The study was funded by a revered organization and conducted at a recognized institution. Yet Stryker waited four months to act on the study, allowing more patients to receive defective implants in the mean time.

Stryker Downplays Their Device’s Fault

Though Stryker has issued a recall for their implants, they continue to downplay the fault of their devices. They’ve made no mention of the high failure rate, nor of the possibility for heavy metal poisoning.

Their recall statement states:  “We decided to voluntarily recall these modular-neck stem hip systems because there is a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.”

Many patients who have a Stryker implant aren’t even aware that there’s a recall for their implant. The language on Stryker’s website downplays the potential life-threatening danger of continuing to use a Stryker device, potentially leading more patients to choose not to take remedial action.

If you’ve been injured by a Stryker device, whether from implant failure or from metal poisoning, we can help you get the compensation you deserve. To learn more, contact us at (888) 424-5757.

When And What Did DePuy Know About The Dangerous Defects With Their Hips?

As the over 10,000 pending civil cases await trial, the question that is being asked in litigation preparation is exactly when Johnson & Johnson’s DePuy division found out that there were defects in their product and what information did they conceal from the public? The first case has already been tried and resulted in an $8.3 million verdict for the plaintiff. The second case is already under way in state court in Chicago, IL and many more are to come that will debate the same question in front of a jury.

Metal-On-Metal Hip Implant Problems

Although DePuy did not recall its ASR XL Acetabular metal-on-metal (MOM) hip replacement until 2010, it is being debated that they knew years earlier that there was a problem. These MOM hip implants were touted in the beginning to last 20 years for patients and now even DePuy admits that almost 40% of the implants will need to be replaced within five years of the implant. On top of the replacement or revision surgery, patients may suffer from tissue and muscle damage and may be exposed to dangerous metal poisoning as well.

Knowledge Of Design Flaw Prior To A Withdrawal From The Market

In the second trial, there is speculation that DePuy knew that there were problems with the design of their product back in 2008, two years before they recalled the device. The attorney for plaintiff has revealed that DePuy discovered flaws in the design in 2008 and considered redesigning the device. However, they did not follow through with the redesign and failed to alert surgeons about the risks of the device.

DePuy even tried to downplay the issues with their device after the recall in 2010.  Internal documents from DePuy showed that in 2011, their own internal analysis of their device showed that there was a 37% fail rate in the first five years. However, publicly they denied these facts. When the National Joint Registry of England and Wales estimated that the fail rate was nearly at 1/3 in 2011, DePuy said these numbers were not accurate, even though their own research showed that the fail rate was actually even higher.

The lawyers in both the current case and the thousands to come point to memos and emails as well as testimony from the lead ASR designer, Magnus Flett, that the company did know there were problems well before the recall. This adds to their liability of not only creating a defective product that is causing serious health risks but that they were aware of the problem and did not react proactively to reduce harm to the thousands of patients with these devices in their bodies. As more cases go to trial, it remains to be seen what effect this evidence will have on the outcomes of the pending cases that will be in front of the courts in the months and years to come.

For more information about the pending DePuy trials, please review:

http://www.bloomberg.com/news/2013-03-11/j-j-faces-second-trial-over-recalled-hip-after-losing-first-case.html

http://en.wikipedia.org/wiki/2010_DePuy_Hip_Recall

http://washpost.bloomberg.com/Story?docId=1376-MHB8HF1A1I4H01-2JTNTN721JJQ2COU9HKFVFCP9V

http://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0

Stryker Hip Revision Surgeries Present Multitude Of Complications

Metal on metal hip implant manufacturers have long tried to downplay the severity of revision hip replacement surgery. Revision surgery is not the same procedure as hip replacement surgery. People often assume that just because the hip replacement surgery was relatively easy, that revision surgery would be similar. Unfortunately, it doesn’t work that way.

Hip revision surgery is far more risky and dangerous than the original surgery. The costs and side effects shouldn’t be minimized.

Side Effects and Complications Associated With A Stryker Revision Surgery

Here are some of the many risks and complications that accompany revision surgery:

  • Dislocation. The risk of dislocation is much higher with revision surgery. Between 2% and 26% of patients will experience dislocation, depending on the specific circumstances procedure.
  • Bone loss. Bone surrounding the old implant will often need to be removed. In mild cases revision femoral stems can be used. In many cases, bone grafting and bone stock implantation is necessary.
  • Tissue loss. This often happens with metal on metal implants. Tissues around the metal on metal surface will often have metal poisoning an need to be removed.
  • Nerve damage. Between 3% to 8% of patients experience nerve damage.
  • Arterial or vein damage. Blood vessels can get damaged during the procedure.
  • New bone formation. Revision surgery can cause bones to form in unnatural places.
  • Bacterial infection. Areas around the surgery area can get infected.
  • Cracked thigh (femur) bone. This can require further surgery to correct.
  • Extended rehabilitation. Rehabilitation from revision surgery will take longer than the original hip implant.
  • Death of the patient.

Why Are Revision Surgeries More Difficult?

Performing a revision surgery requires more complex equipment than an initial surgery. A specialist may be required to perform the operation, as many of the procedures are rare and require specialized skills. Bone grafting equipment is often required, along with surgeons who can perform bone grafting procedures.

Revision surgery is also more difficult because the area surrounding the implant has weakened. The mechanical components inside the metal on metal implant tend to loosen and wear over time. As these components loosen, they subtly take up more space in the body. This causes the body to slowly leak bone fluid, which dissolves and is re-absorbed into the bloodstream, causing a loss of bone density. This causes a process called bone resorption.

In other words, the bone structure surrounding the implant loses some of its calcium. This weakens the overall area, making the scaffolding necessary for hip implants weaker. The younger and more active the patient, the faster this process happens, as younger individuals tend to be more physically active.
The loss of bone and surrounding tissue can also make it difficult to get a tight fit with a new implant. In order for a hip implant to function properly, it needs to tightly fit into the hip socket. With the removal of bone and tissue, more space is created, which often means additional procedures are needed to get the implant to fit tightly.
Hip revision surgery is physically taxing on the patient and expensive. Though manufacturing companies have often tried to downplay the complications, the truth is that these surgeries are painful and dangerous. If you’ve had to undergo hip revision surgery because of a metal on metal hip implant failure such as a Stryker or DePuy, you may be entitled to financial compensation. Contact us here or call us directly (888) 424-5757.