Cobalt Chromium Toxicity

stryker hip recall

Adverse local tissue responses in hip implants with dual-taper stems


Within the last two decades, modularity in hip implants became the prevalent paradigm. Modularity means prosthetic hip implant components are available in multiple segments, or parts, as opposed to a single piece (monoblock implants). Modular components generally consist of a femoral stem with an extra modular junction between the neck and stem body, known as a dual-taper stem. Dual-taper stems are popular since they allow for variations in length, shape, size, degree of offset, and rotation of the implant. Most hip replacement manufacturers have models with the modular neck design option.

However, this extra modular junction is under scrutiny for potentially causing corrosion between the neck and body stem. Studies show metal debris and adverse local tissue reactions (ALTR) secondary to taper corrosion at the head-neck junction analogous to patients with failed metal on metal hips. This study highlights patients with ALTR from modular neck-body junction corrosion.

The study involves eleven patients, eight women and three men; with a total of twelve hips (one patient had bilateral total hip arthroplasty). The patients were evaluated for ALTR secondary to modular femoral neck-body taper junction corrosion. According to the study, the patients presented with pain approximately 8 months after their initial surgery. The pain among the patients was mainly localized in the groin. However, some patients pain radiated to their buttocks, trochanters (parts of the femur), or thighs. Others experienced severe limps, weakness, and significant leg swelling. Stryker rejuvenate was among the models of implanted metal on metal hips in the patients. Patients were all implanted with hips constructed with a cobalt-chromium alloy modular neck and a titanium-alloy stem.

Before undergoing revision surgery, patients had a preoperative workup. The preoperative workup included blood tests which analyzed elevated white blood cells (checking for inflammation), erythrocyte sedimentation rate (reveals inflammatory activity), and serum metal ion levels (checking for metal sensitivity). Additionally, patients underwent a metal artifact reduction sequence (MARS) MRI to evaluate for any abnormalities.

Serum metal ion lab results demonstrated considerable elevation in serum cobalt and serum chromium levels (cobalt was worse than chromium). The MARS MRI indicated large fluid collections and hypertrophic soft-tissue reactions (pseudotumor formation) in ten of the eleven patients (90.9% of patients). Patients were later diagnosed with taper corrosion and underwent revision surgery roughly 9 months after their symptoms first appeared. Revision surgery in the patients revealed capsular hypertrophy (increased tissue growth) and necrosis (death) of the soft-tissue structures involving the hip joint. Several patients had large soft-tissue masses. The modular junction between the femoral component neck and body established marked corrosion, with taper fretting and black, flaky material deposits at the base of each hip. Microscopic testing showed obvious corrosion at the modular femoral neck-body junction in all devices along with fretting and metal debris.

This study confirms dual-taper stem designs with modular cobalt-chromium-alloy necks may cause pain and significant soft-tissue destruction and death surrounding the implanted hip eventually leading to joint failure. Adverse local tissue reactions and metal debris result from fretting and corrosion at the head-neck junction of the cobalt-chromium alloy head and cobalt-chromium alloy stem. Extensive pitting corrosion and fretting was found in many patients. Head-neck taper corrosion resulted in elevated serum cobalt and serum chromium levels. The cobalt levels were much higher than chromium in the cobalt-chromium alloy.  Blood tests also determined inflammation due to adverse local tissue responses secondary to taper corrosion. The study establishes substantial soft tissue damage from corrosion at the modular neck-body taper of a dual-taper femoral model.

Source: Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual- Taper Stem with a Cobalt-Chromium Modular Neck, The Journal Of Bone and Joint Surgery

Recall Attorneys Guide Patients with MoM Hip Implants


The civil justice law firm of Kershaw, Cook & Talley provides a comprehensive list of questions patients with metal on metal hip prostheses should ask their doctor.

Kershaw, Cook & Talley represents hundreds of individuals dealing with the physical and emotional toll from their defective hips. The partners at the firm are dedicated to providing the latest information concerning Stryker Rejuvenate and Stryker ABG II prostheses.

Many of our clients receive different opinions, and treatment options, regarding follow-up for their defective metal on metal hips. Some clients were informed revision surgery was a necessary solution, while others were told monitoring via repeat blood tests, x-rays, and physical examination was sufficient.

Kershaw, Cook & Talley attorneys compiled a list of questions every Stryker patient should ask their surgeon regarding the best course of action. The list serves as a guide to ensure your clinician takes the appropriate steps necessary for your treatment and protection.

For the comprehensive list, please refer to Questions To Ask Your Doctor.

Kershaw, Cook & Talley is a Sacramento-based firm representing individuals nationwide in defective medical device cases. The firm generates hundreds of millions of dollars in recoveries for their clients and the classes they represent. Individuals impacted by Stryker’s hip systems are entitled to compensation for wage losses, medical bills, and pain and suffering. For a free case evaluation, and more information about the status of the case, feel free to call Bill Kershaw or Stuart Talley directly at (916) 520-6639 or log onto https://www.cobalt-chromium-toxicity.com

 

Deadline Looms for Stryker Rejuvenate and ABGII Recall Victims


On June 29, 2012, Stryker announced the recall of more than 20,000 Rejuvenate and ABG II hips implanted in patients throughout the United States. These hips are alleged to have a very high failure rate. However, to date, only a small fraction of those with recalled hips filed lawsuits.  Attorneys at Kershaw, Cook & Talley are concerned individuals with affected hips may lose their opportunity to recover damages if they fail to file a claim before June 29, 2014.

In most states, the statute of limitations, or time in which you can file a lawsuit, is approximately two years.  Stryker could possibly argue this statute of limitations began to run on June 29, 2012; the date it first announced a recall of its Rejuvenate and ABGII hips.  Therefore, many victims will need to file their lawsuits before June 29, 2014.

Kershaw, Cook & Talley partner, Stuart Talley, reports,  “Over the past few days, many people are calling in.  People are very concerned about the statute of limitations and want us to file their cases prior to the June 29 deadline.”

According to Mr. Talley, the date the statute of limitations begins to run is not always set in stone. Stryker may argue it ran on the date it announced the recall even if the plaintiff was unaware of the recall.  Furthermore, Stryker might claim the deadline begins to run whether or not an individual underwent revision surgery or experiences any issues with their hip.

Specifically, Mr. Talley notes,  “People are unaware that if your hip is not hurting, or your doctor has not recommended surgery, the statute of limitations could arguably be running on your case.  It may be too late to bring a claim if you wait until your doctor says you need surgery. In order have protection down the road, it is critical to contact an attorney immediately.”

The attorneys Kershaw, Cook & Talley set up a statute of limitations information page which provides extensive information to victims.  On this page, Stuart Talley provides detailed information via video concerning the statute of limitations and how Stryker Rejuvenate recipients should proceed to protect their interests.  This website is just one of many Kershaw, Cook & Talley created in order to provide information for people impacted as a result of the Rejuvenate recall.  The most popular sections of the Cobalt Chromium Toxicity website include pages regarding cobalt and chromium toxicity, a medical research library, a reference page for Rejuvenate victims, and monthly updates on the Stryker rejuvenate litigation.

Kershaw, Cook & Talley is a Sacramento-based firm representing individuals nationwide in defective medical device cases. The firm generates hundreds of millions of dollars in recoveries for their clients and the classes they represent. Individuals impacted by Stryker’s hip systems are entitled to compensation for wage losses, medical bills, and pain and suffering. For a free case evaluation, and more information about the status of the case, feel free to call Bill Kershaw or Stuart Talley directly at (916) 520-6639 or log onto https://www.cobalt-chromium-toxicity.com

U.S. Food and Drug Administration (FDA) link about the Stryker Hip Recall (July 6, 2012):http://www.fda.gov/safety/recalls/ucm311043.htm

Metal on Metal Hip Prostheses and Total Hip Arthroplasty Effects on Auditory and Visual Health


In the United States, there are over half a million patients implanted with metal on metal (MOM) hip prostheses. The typical elements released by the metal on metal hip prostheses are cobalt and chromium. The normal levels of cobalt and chromium within the body are below a microgram per liter of blood, or below a part per billion. The term microgram per liter is analogous to parts per billion. There are studies demonstrating that a normal range is within 0.1 to 0.3 micrograms per liter. According to this study, patients with well functioning MOM hips, had cobalt-chromium blood levels between 1.5 and 2.3 micrograms per liter. This is ten times higher than normal physiological levels and significantly contributes to the potential for cobalt-chromium toxicity, or metallosis. In association with metallosis, the study indicates that failure with prostheses was connected to visual and auditory issues resulting from elevated cobalt-chromium levels. There is a strong correlation between device failure with visual and auditory dysfunction.

In addition to the aforementioned findings, the study determines whether or not chronic low levels of metal exposure result in obvious physiological effects on the auditory and visual systems as well. In order to determine the effects of chronic low levels of cobalt-chromium, participants met with both an otolaryngologist and an ophthalmologist in order to determine primary or pre-existing pathologies within the ears and eyes, respectively. Subjects then underwent objective and subjective audiometric testing in order to assess auditory health and function. Similarly, the subjects demonstrated their visual health and functioning via subjective and objective visual testing. There were two types of participants in this study: those with MOMHR and those with total hip arthroplasty (THA). The participants in this study were then separated into groups based on their age and time since surgery. The participant’s blood tests also revealed that those with MOMHR had a blood, plasma, urinary cobalt and chromium levels that were 5 to 10 times higher than the THA participants. In terms of objective audiometric and visual findings between the MOMHR and THA groups, there was no observable difference, and patients in each group had similar auditory and visual function.

There is no conceivable evidence between MOMHR and altered brain stem responses for patients with exposure to chronic low metal levels. However, there is optic nerve atrophy (damage) in patients with exposure to high metal levels in their system  which reflects visual loss among this specific population. Whereas patients with long term exposure to low metal levels had no obvious association with auditory or visual defects, the patients with malfunctioning hip prostheses and elevated metal levels (up to hundreds in micrograms per liter) suggested visual and auditory defects.

Source: Auditory and Visual Health after Ten Years of Exposure to Metal-on-Metal Hip Prostheses: A Cross-Sectional Study Follow Up http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0090838

 

Influence of Femoral Stems with Modular Neck Designs on Health Consequences and Presence of Metal Ions


Metal on metal (MOM) prostheses have different designs. One such MOM stem design, Profemur Z, includes a femoral stem with a modular neck that enables adjustments which are separate from femoral fixation. There is concern with the potential for fracture of the modular neck in relation to the modular junction. Fracturing of this junction may potentially lead to the production and release of metal debris and ions causing adverse local tissue reactions, or ALTR.

The Profemur Z allows for a modular neck-body junction which can be inserted with a variety of orientations, angles, and directions. The neck has a taper where a modular head may attach. These models only used titanium alloy necks until cobalt chromium alloy necks were available. There are many cases of corrosion and modular neck fracture secondary to failure of the Profemur Z stem design. According to the Australian Orthopedic Association’s National Joint Replacement Registry, there is an 11% failure rate for patients with this device over a 5 year period. This is a significant failure rate compared to other femoral stems.

An increase in serum chromium and cobalt levels was indicated in patients with MOM hip prostheses. The modular head-neck junction, and bearing surface, is the main cause of the cobalt and chromium release in the blood stream. There was a significant elevation in cobalt and chromium serum levels as a result. Whereas titanium alloy prostheses, had low elevations of cobalt and chromium serums, the adverse local tissue reaction, results from the release of cobalt and chromium in those stem designs produced with a modular neck made from a cobalt-chromium alloy. The etiology of modular neck fractures stems from fatigue failure and crack formation from corrosion due to metalurgical reactions of the device with body chemistry. In addition, those stem designs with a modular neck-body junction made of both chromium-cobalt and titanium have the ability to cause even more detrimental local tissue reactions.

Crack formations on the neck-body interface are the result of oxide-formation and oxide-driven stress. Over time, pitting and formation of cracks are exacerbated by increased stress corrosion and oxidation surrounding the interface of the mechanism. Stress corrosion causes the dissolution process of metal ions. The consequences of elevated metal ion levels from the cobalt-chromium stems in patients include pseudotumor formation, severe pain, osteolysis, and taper corrosion.

Subsequently, there is an increased revision rate for prostheses with this femoral stem design. During revision surgeries, findings illustrated significant corrosion at the modular neck-body interface.

The Full Article can be read at:

http://www.arthroplastyjournal.org/article/S0883-5403(14)00297-6/abstract

Source: Silverton Craig D., Jacobs Joshua J., Devitt Jeffrey W.,
Cooper H. John, Midterm Results of a Femoral Stem with a Modular Neck Design:
Clinical Outcomes and Metal Ion Analysis, Journal of Arthroplasty (2014), doi:
10.1016/j.arth.2014.04.039

March 2014 Stryker Hip Recall Litigation Update


Hi, I’m Stuart Talley with Kershaw|Talley.  I’m the partner here responsible for providing an update on the status of the Stryker Rejuvenate and ABG II hip litigation.  We are happy to report that the court has recently set several important deadlines that will begin moving this case forward at a fairly rapid pace. This is the latest update for March 2014 Stryker Hip Recall Litigation Update.

As previously reported, we have had a very difficult time getting Stryker to cooperate in discovery.  To date, they have only produced a small fraction of the documents we have requested and have not yet produced any witnesses for deposition.  At the same time, Stryker is repeatedly advising the court that it is settling cases in other jurisdictions.  It appears its strategy is to convince the judge that no discovery should take place in our case since all of the cases will eventually be settled through its “settlement program.” Entire blog →

Stryker Hip Recall: Cancer Study


Hi, I’m Stuart Talley with Kershaw, Cook & Talley. Bill Kershaw and I are the partners responsible for providing updates on the Stryker Rejuvenate and Stryker ABG II litigation case.

I am providing an update concerning recent developments about cobalt and chromium toxicity. The developments discuss whether or not high doses of the metals can cause or increase the risk of cancer. Recently, there was a scientific study issued from Finland. In the paper, the scientists examined individuals with metal on metal hips who had high cobalt and chromium levels. They compared these individuals with others implanted with metal-on-plastic hips. This specific research is ongoing since people continue to experience issues with metal on metal hips, and the release of cobalt and chromium ions from their hip joint.

So far, there are no studies suggesting a correlation between elevated levels of cobalt and chromium in the blood and an increased risk for cancer. However, this does not negate the fact that there may be a link; there is just no current evidence to substantiate a link.

In the Finland study, doctors analyzed 10,000 patients with metal on metal hips and compared them to 18,000 patients with conventional metal-on-plastic hips.  They found no statistical increase in the rate of cancer between the two groups from their previous study in 2012. Europe is making a conscious effort to monitor patients with metal on metal hips and metal-on-plastic hips in order to assess the risk of cancer. The link between metal on metal hips and an increased risk for cancer may become apparent in the future.

We represent hundreds of individuals with various metal on metal hips including Stryker Rejuvenate and Stryker ABG II. If you have any questions or concerns, please call us, toll free, at (916) 520-6639 or visit our website www.defectivehipsettlementcenter.com and fill out the contact form for a free evaluation.

Stryker Hip Recall Lawyer: Statue of Limitations


Hi, I’m Stuart Talley with Kershaw, Cook & Talley. Bill Kershaw and I are the partners responsible for the Stryker Rejuvenate and Stryker ABG II litigation cases. Today, I am providing information about the statute of limitations on some cases.

The statute of limitations is a very important issue concerning the litigation.  The Stryker Rejuvenate and Stryker ABG II hips were recalled in July 2012. Stryker can potentially argue the statute of limitations for their recalled hips begins to run on that date. In most states, the statute of limitations is two years. The statute of limitations could run on your case in July 2014; even if you haven’t undergone revision surgery or experienced any symptoms.

If you have a Stryker Rejuvenate or Stryker ABG II, get in touch with an attorney immediately to ensure your case gets on file or have an agreement with Stryker stopping the statute of limitations from running. We are currently discussing a tolling agreement with Stryker. A tolling agreement is an agreement with the defendant stating you don’t need to file a lawsuit and the statute of limitations will stop the day you enter the agreement.

If you have any questions or concerns, please call us, toll free, at (916) 520-6639 or visit our website at www.defectivehipsettlementcenter.com  and fill out the contact form for a free evaluation.

Stryker Hip Recall Attorney: Questions to ask your doctor


At Kershaw, Cook & Talley, we represent hundreds of individuals with defective hips. After reviewing thousands of medical records, and speaking with numerous orthopedic surgeons, we discovered alarming variations in the way orthopedic surgeons deal with patients implanted with Stryker Rejuvenate or ABGII hips. There are surgeons who are aggressive in their treatment and opt for revision surgery. Others, err on the side of caution and closely monitor their patients via repeat blood tests, XRAYS, and physical examination. In addition, many surgeons have little information on the most recent science regarding cobalt and chromium toxicity, and the impact these metals can have on your body.

For your convenience, we compiled a list of questions every Stryker patient should ask their surgeon. This ensures your clinician is taking the appropriate steps necessary for your treatment while aiding an understanding of his or her opinions with respect to your hip. We hope these questions are helpful. If you have any comments or concerns about your doctor’s answers to these questions, please feel free to contact us at (916) 520-6639 or by email at [email protected] and [email protected]

QUESTIONS TO ASK YOUR DOCTOR

  1. What is your understanding as to why the Rejuvenate or ABG II was recalled?
  2. What types of tests do you believe should be performed to make sure that metal ions from my Stryker hip are not causing tissue damage in my hip?
  3. What types of complications can result from tissue damage?
  4. What types of things do you look at when deciding to recommend revision surgery?
  5. Should I be getting a blood test to determine the amount of titanium in my blood, in addition to blood tests for cobalt and chromium?  Are there any known risks associated with titanium?
  6. How much cobalt and chromium in my blood is too much?  Do I have to be worried about any long term health issues such as cancer, thyroid disorders, or heart issues?
  7. What do the most recent studies say about the health impacts of having high levels of chromium and cobalt in my body?
  8. What is your understanding of the revision rates for the Stryker ABG II and Rejuvenate hips?
  9. If you think my hip is likely to fail in the future, is there any reason to wait until the metal ions have caused damage to my hip before having surgery?
  10. If I don’t have revision surgery, should I be getting my blood tested for cobalt and chromium on a regular basis?  If so, how often?
  11. If I don’t have revision surgery, should I be getting MRIs performed on a regular basis?  If so, how often?
  12. What are the risks of having revision surgery?
  13. What does revision surgery entail?  Will you be removing all of the hardware?
  14. How many revision surgeries have you personally performed where the stem had to be removed?  What is your complication rate with these surgeries?
  15. After revision surgery will the rehab be different than my first operation?
  16. Do I need to be more concerned about fracturing my femur during rehab since you are replacing the stem?
  17. In what percentage of the revision surgeries performed by you, were you able to remove the stem without fracturing the femur?
  18. What type of hip would you use to replace the Stryker Rejuvenate or ABG II?
  19. How long is the recovery period expected to be after revision surgery?

Stryker Hip Recall Lawyer: Does the Doctor need to be named in the Lawsuit


Hi, I’m Stuart Talley with Kershaw, Cook & Talley. Bill Kershaw and I are the partners responsible for the Stryker Rejuvenate and Stryker ABG II litigation cases.

Today, I am answering a frequently asked question concerning whether or not you need to sue your doctor. The answer is no. Your doctor does not need to be named in the lawsuit. We highly recommend against naming your doctor in any of these cases; we have not named a doctor in any of our hundred cases.

The primary reason is that the doctor is not at fault. The Stryker Rejuvenate and Stryker ABG II were provided to the doctor under the false pretense that the hips were not defective. Both the doctors and patients are innocent victims. Another reason is the doctor is often a very important witness in these cases. You want the doctor to provide positive testimony and be on your side. You would only want to name the doctor in rare circumstances. The goal is to hold Stryker responsible since they are at fault.

If you have a Stryker Rejuvenate and Stryker ABG II, please call us, toll free, at (916) 520-6639 or visit our website at www.defectivehipsettlementcenter.com  and fill out the contact form for a free evaluation.

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