Replacement

Stryker and metal hip replacement issues and information.

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.