Extraction Protocol Regarding Stryker ABG II Hip Implants

When the Stryker ABG II was originally marketed it was believed to be a safe alternative to the metal-on-metal hip implants which caused so much damage to recipients. Even though the ABG II does not have the same amount of metal surface to rub together, some of the metal neck junctures have shown signs of corrosion and the metal trunnions, located on either end of the neck portion have also been subject to corrosion when body fluids become trapped underneath.  Once corrosion and fretting occur, the threat of tissue necrosis, bone loss, total implant failure and symptoms of metal toxicity can follow.

Initially surgeons were impressed with the ABG II and the Rejuvenate because of the new modular design which allowed them to choose a stem, neck, ball and cup based on the activity level and size of the individual recipient. This extra flexibility was also meant to give patients a better, longer-lasting hip implant. Unfortunately, the promise of this new design did not pan out, and soon many recipients of the ABG II began to experience inflammation and pain as well as symptoms of metal toxicity.  Those patients who experienced significant problems early on were likely advised to undergo revision surgery in order to remove the Stryker ABG II, however this is not the easy decision it might seem despite the serious adverse symptoms.

Because of the weakened bone and tissue which results from corrosion of the ABG II, there is a significant risk of dislocation following revision surgery. In many Stryker ABG II revision surgeries the femur bone will fracture from the stress of removing the stem of the implant. Revision of the ABG II is considered much riskier than the original hip replacement surgery as the process is much more complex. The ABG II revision surgery can take much longer than the original hip replacement surgery which increases risk of infection and blood loss.

There is a protocol for the removal of the Stryker ABG II which includes removal of the neck implant piece with an ABG II Modular Neck Extractor which is placed under the medial or lateral side of the base of the neck. Neck Trial Forceps are recommended as a means of “catching” the neck during the extraction; should the neck be resistant to removal it is recommended that the Neck Extractor end be tapped in a controlled manner with a mallet. The stem of the Stryker ABG II will next be removed using a Modular Stem Extractor with a connection pin which engages the stem insertion feature and incorporates a locking arm which engages the taper. The threaded locking knob will be tightened which secures the arm. Finally, the stem impactor will push the stem from where it is inserted into the femur.

Extracting the stem is likely the most difficult part of the revision surgery and some orthopedic surgeons have likened it to removing a piece of rebar from a slab of concrete. StrykerABG II revision surgery can require extra bone material obtained from a bone bank when the stem is removed as the bone can shatter. Because of the additional recovery time, patients who undergo revision surgery to remove a defective ABG II can face exorbitant medical expenses, lost wages from their inability to return to work, short or long-term disabilities and interruptions to their daily routines for considerable lengths of time.

Information and Actions to Consider Regarding the Stryker ABG II and Rejuvenate Hip Implants

This past July, both the Stryker ABG II and the Rejuvenate hip implants were recalled due to the risk of fretting and corrosion. When corrosion occurs inflammation can result, the recipient may experience chronic pain and tissue and bone degradation and loss can occur. When the bone and tissue around the hip implant begin to deteriorate, the implant can loosen and total failure of the implant can occur. Many patients have experienced implant failure and have been advised by their physician they must undergo revision surgery to have the recalled implant removed and replaced with a ceramic or polyethylene hip device.

Other patients have experienced metal toxicity when the microscopic metal shards enter the bloodstream and cause gastrointestinal, cardiovascular, renal and thyroid problems as well as vision and hearing disturbances, vertigo, DNA disruption, anxiety, depression and irritability. There are certain things you must do in order to protect your right to compensation should you have already had problems with your Stryker implant or have problems in the future.

If you do not already know the name of the surgeon who performed your initial hip implant, it’s important to find that information as he or she could be called to testify during a lawsuit. Whether you have had problems yet or not, see your physician for a complete medical workup and diagnosis to determine your levels of cobalt and chromium and to find out whether your implant has loosened. Ask your surgeon whether he or she feels you should have revision surgery—then get a second opinion from another surgeon.

While there will be class action suits filed against Stryker, you should definitely speak with an attorney before deciding to join in such a suit. Taking part in a class action suit can leave you without your medical expenses covered and you may receive no compensation for pain, suffering, or lost wages. Hopefully you have kept comprehensive records from the very beginning of your implant surgery, but even if you have not, begin now. Record any pain or other symptoms you have suffered following the implant as well as how your daily life has been impacted. Keep a record of each doctor seen and every treatment recommended.

Don’t delay treatment because you are considering a lawsuit, and continue working as long as you are able. Speak to an attorney as soon as possible to ensure you do not exceed the statute of limitations. Because the failure rate is relatively high for these recalled implants, the fact that you have not yet experienced problems related to the implant is no indication that you will not have problems in the future. Stryker is not likely to simply write you a check for your medical expenses and the trauma you have experienced. Knowledgeable attorneys understand the importance of preserving evidence and will not try to convince you to file a lawsuit unless they are convinced you have a solid case.

New Jersey Establishes Multi-County Litigation for Stryker Rejuvenate & ABGII Hip Implants

After the recall of the Stryker ABG II and Rejuvenate hip implants in July, 2012, lawsuits began pouring in following the lead of the DePuy ASR hip implant recall. In January, 2013, a multi-county litigation was established for the suits against Stryker in the Bergen County Superior Court under Judge Brian R. Martinotti. Three months prior to the issuance of the Stryker recall, notice was sent to surgeons and hospitals regarding the potential risks involved for those with an ABG II or Rejuvenate implant. The specific risks included corrosion and fretting at the metal neck junction which could lead to microscopic metal shards burrowing into surrounding tissue or entering into the bloodstream.

Once corrosion and fretting occurs, the implant recipient can suffer inflammation, chronic pain, loss of tissue or bone, loosening of the implant or joint dislocation. Any of these serious symptoms can result in the necessity of a revision surgery to replace the defective hip implant device. Pseudo-tumors can also result from the cobalt and chromium ions and, once formed, require surgery to remove. Symptoms of metal toxicity such as cardiovascular, renal thyroid and gastrointestinal disorders, disruption of DNA, vertigo, skin problems, memory loss, anxiety and depression can all occur when cobalt and chromium have built up in the body to a certain level. Some people are more vulnerable to metals in the body than others, but there really are no safe levels of toxic metals in the body.

Stryker is expecting to pay out almost $400 million dollars in legal fees, costs for revision surgeries, blood tests, x-rays and MRIs for the 20,000 recalled hip devices implanted in recipients. Following the recall Stryker advised those patients who were having any type of trouble related to the implant to seek the advice of their physician. Even those who are not currently experiencing problems with their implant should undergo blood tests and image screening since a large percentage of the implants experienced failure within 3-5 years following the initial implant. Although 81 lawsuits have been filed against Stryker in this latest New Jersey multi-county litigation, it is expected there will be many more to come between now and the time the statute of limitations runs out. On March 19, 2013, a case-management conference regarding the multi-county litigation took place.

Stryker is one of the largest manufacturers of orthopedic devices, generating over $8 billion in annual sales in 2012, and ranking at 308 on the Fortune 500. This is due in part to the fact that when the companies who manufactured metal-on-metal hip implants began having lawsuits filed against them Stryker picked up that share of the hip implant market due to the fact that the company was offering an innovative design which included several neck and stem components which gave surgeons greater flexibility in custom fitting the implant to the specific patient. The stems were manufactured using Stryker’s titanium alloy blend which they claimed would resist the effects of corrosion and fretting.

Despite this claim, post-market data revealed evidence of corrosion and fretting, serious side effects including implant loosening and the release of toxic metals which eventually led to the recall. The hip implants which were intended to last considerably longer than ceramic or polyethylene implants began failing within the first two, three and four years following the initial implant. The first DePuy ASR lawsuit was recently settled for a staggering $8.3 million dollars; many believe this is an indication of how the thousands of hip implant lawsuits will continue to resolve, perhaps including the Stryker ABG II and Rejuvenate lawsuits as well.

Lawyers for Stryker Patients Urge Them to Move Quickly

Attorneys familiar with the Stryker ABGII and Rejuvenate hip implant recalls this past June are urging recipients of the all-metal hip implant to act quickly even if they have yet to experience adverse health effects from their implant. Stryker has already increased the amount of money set aside to cover the costs of the Stryker recall to between $190 and $390 million dollars. This money is meant to cover revision surgeries required by implant recipients, blood tests, MRIs, X-rays and the cost of insurance and impending lawsuits. While the all-metal hip implants were meant to last considerably longer than their ceramic and polyethylene predecessors, once thousands of people had been implanted with the metal-on-metal hip implants adverse reports starting coming in.

The Problem with All-Metal Hip Implants

When the cobalt and chromium implant parts rub against one another while the patient is walking, running or engaging in other normal day-to-day activities, the small metal ions shear away, becoming lodged in surrounding tissues or entering the patient’s bloodstream. Bone loss, tissue destruction and death and chronic pain are all reactions to the inflammation which occurs when the metal shards burrow into the hip tissues. When the cobalt and chromium enter the bloodstream, metal poisoning or toxicity can occur. The higher the metal levels in the body, the more likely the patient is to experience significant and negative health issues including: cardiovascular, renal, thyroid and gastrointestinal disorders, hearing and vision disturbances, anxiety, depression, memory loss, vertigo, skin issues, pseudo-tumors and disruption of DNA.

Failure Rates of Metal-on-Metal Hip Implants

Depending on the manufacturer and model of the all-metal hip implant, the failure rate can be as high as 40-60% in the first 4-5 years. Considering the magnitude of this failure rate, all those with a Stryker ABGII or Rejuvenate—or any other all-metal hip implant—would be well-advised to see their physician to have the necessary tests which will determine cobalt and chromium levels in the body as well as to consult with an attorney who is experienced in the all-metal implants. Even those implant recipients who have yet to experience significant health problems have a very good chance of developing those problems in the future. In order to ensure that the statute of limitations has not passed, leaving them with no help at all, implant recipients need to take action now.

Will Stryker Follow DePuy’s Lead?

It is likely that Stryker will follow the lead of DePuy and Johnson & Johnson who are currently embroiled in over 10,000 lawsuits over the recalled ASR hip implant. Over six-thousand lawsuits will be resolved in Federal Court under an MDL while the remainder will have their cases tried in state courts across the United States. Currently the first DePuy ASR is taking place in California and is in its fourth week. DePuy and Johnson & Johnson are attempting to shift the blame from the hip implant itself to the Plaintiff’s prior medical issues. Stryker will likely follow suit once Rejuvenate and ABGII lawsuits make it to a courtroom.

The Broadspire Connection

Stryker recently brought Broadspire—a third-party risk-management company—into the mix just as DePuy did following their ASR recall and subsequent lawsuits. Broadspire attempted to manage the DePuy lawsuits by sending out what is known as the “Broadspire letter,” which allowed Broadspire access to the medical records of those patients who signed the letter. Most lawyers believe this was a calculated move on Broadspire’s part. The theory put forth by many plaintiffs’ attorneys was that once they had access to victims’ medical records DePuy and Johnson & Johnson could use a patient’s prior medical history to shift the focus from the harm done by the metal hip implant.  Loren Kransky, the plaintiff in this first DePuy trial had cobalt levels nearly eight times the amount considered safe in his body prior to his revision surgery, yet it is almost a given that DePuy, Johnson & Johnson, and Stryker will do everything in their power to keep their financial exposure to a minimum.

How Broadspire May Influence the Stryker Recall Lawsuits

Just like DePuy and Johnson & Johnson before them, it appears that Stryker may be bringing in Broadspire Services—a third-party risk-management company—to assist with the lawsuits being brought against Stryker following the recall of the ABGII and Rejuvenate hip implant systems. It is likely that when worried patients pick up the phone to call Stryker in order to determine their options they will be referred to Broadspire. It’s very important that recipients of the defective ABGII and Rejuvenate be aware that by signing anything Broadspire recommends they could be putting their future at risk by signing away very important legal rights. Therefore, all patients whose lives have been diminished due to the recalled Stryker hip implants should ensure they have discussed their specific situation with an attorney before they reach out to Stryker or Broadspire.

The Stryker ABGII and Rejuvenate Recall

The ABGII and Rejuvenate hip implants were recalled in June, 2012, due to the potential of fretting and corrosion. This fretting or corrosion can lead to heavy metal poisoning when the friction causes metal ions to shear away, finding their way into surrounding tissue or into the bloodstream. When the ions burrow into the hip tissues, inflammation and pain can result. The longer metal ions are released, the more serious the problem in the hip joint. Tissue destruction and death can occur as well as bone loss and while bone loss can be addressed by doctors, tissue loss cannot. In fact, an orthopedic surgeon who practices at the Mayo Clinic in Jacksonville, FL states that “…if the muscle is dead because it has been poisoned by metal ions, we can’t recreate it.” The metal ions which enter into the bloodstream can cause an array of negative health issues including:

·         Gastrointestinal disorders

·         Cardiovascular events

·         Renal and thyroid problems

·         Vision and hearing impairment

·         Disruption of DNA

·         Fatigue

·         Depression

·         Anxiety

·         Loss of memory

·         Chronic headaches

·         Vertigo

·         Skin problems

·         Pseudo-tumors which require surgery

Johnson & Johnson’s History with Broadspire

DePuy and its parent company Johnson & Johnson were under the same rash of lawsuits and problems following the recall of their ASR hip implant in 2010. They quickly brought Broadspire on board to manage patient questions and claims. A large number of DePuy patients received a letter known as the “Broadspire letter” which, in essence, offered to cover the medical expenses related to revision surgery. In return, DePuy implant recipients were required to sign a medical release form which allowed Broadspire—on behalf of DePuy and Johnson & Johnson—to gain access to the patient’s sensitive medical records. While on the surface the offer of help seemed generous, in reality once the patient’s medical records were obtained those records were sometimes used to potentially deny revision surgery, claiming the problems were due to other medical issues suffered by the implant recipients.

Signing the Broadspire letter also, in some cases, waived the patient’s right to future legal claims. Many implant recipients who had not yet experienced problems with their ASR signed the letter, effectively giving up their right to sue in the future should they develop problems later on. Lawyers who are assisting those patients whose lives have been irrevocably altered due to adverse health effects relating to the Stryker Rejuvenate or ABGII implant are extremely concerned that patients may do the same thing when presented with a letter similar to the DePuy Broadspire letters.

Paying Patients for Revision Surgery is Simply Not Enough

Patients who have experienced a failed Stryker hip implant are likely well aware of the far-reaching consequences. Not only will they be required to undergo an even riskier surgical procedure than the original implant, they are also facing a substantially increased recovery time. Most of those who have undergone revision surgery are off work from six to eight weeks. Few people work for an employer who is understanding enough to pay them their regular salary while they are recuperating from revision surgery meaning the normal monthly bills could well go unpaid.

Because many of the Rejuvenate and ABGII recipients were younger and involved in active lives and careers, the necessity of revision surgery could cause significant problems. Aside from the necessity for revision surgery, the buildup of metal ions in the bloodstream may have caused damage which, in some cases, is irreversible. In other words, for those Stryker patients whose lives were forever changed by an ABGII or Rejuvenate hip implant, an offer to pay for revision surgery hardly seems adequate.

The Promise of All-Metal Hip Implants

When the metal-on-metal hipimplant came onto the scene it quickly began replacing polyethylene and ceramic implants for one simple reason: the all-metal hip implants were marketed as lasting much longer than the other commonly used implants—from fifteen years to even twenty. Because the typical life of a polyethylene or ceramic implant is approximately 8-10 years, this seemed like a dream come true for those facing implant surgery.

Yet once thousands of hip implant recipients across the globe were implanted with all-metal hip implants, more and more of those recipients began reporting adverse health effects. It soon became well-known that the metal parts rubbed against one another during times of activity, creating friction which in turn sheared away metal ions which were released into the body. The scores of all-metal hip implant recipients who had been promised a safe, worry-free hip implant quickly found the failure rate for the all-metal implants could even be as high as 40-60% after 3-5 years.

Expected Payout Increased in Light of Increasing Number of Stryker Lawsuits

Like DePuy, Stryker may do their best to place the blame for the failed implants anywhere but on themselves. Claiming the revision surgeries are due to other health issues or mal-positioning of the implant seems to be status quo for manufacturers of metal-on-metal hip implants once the lawsuits begin rolling in. Stryker announced in January they would be increasing their forecasted costs to cover patient testing, treatment, revision surgeries, lawsuits and insurance payments to between $190 and $390 million dollars. Because Broadspire is now in the Stryker lawsuit picture, lawyers familiar with the cases believe Broadspire may attempt to manage costs the same way they did with DePuy, gaining access to the sensitive medical histories of implant recipients.