Cobalt Hip Poisoning From Stryker Rejuvenate & ABGII Hip Implants: 510(k) Approval for the Rejuvenate and ABGII Rather than Full PMA Approval

Cobalt poisoning from hips is becoming more and more common among those recipients of a metal-on-metal hip implant device. Stryker Rejuvenate and ABGII were placed on the market in 2009, yet shortly after adverse reports began coming in regarding side effects of these two Stryker models. The Rejuvenate and ABGII both gained FDA clearance through a process known as the 510(k). To gain this type of clearance a medical device must only show it is substantially equivalent to a similar device. The problem with this type of clearance is that many times the device the new application is claiming to be similar to may have had its own share of safety issues.

There is a much more stringent type of FDA approval known as Premarket Approval or PMA. This approval requires the company to conduct clinical trials and safety testing—essentially to prove the device is safe and effective prior to marketing it to consumers. The 510(k) process requires little in the way of scientific research to prove safety. Further, at the time the Rejuvenate gained its 510(k) approval the neck was not constructed of cobalt and chromium, rather was changed later in 2009 without benefit of further FDA approval. The FDA did ask that Stryker conduct a study known as the Rejuvenate Modular Outcome Study which would follow patients for five and ten years to determine whether they had revision-free wear with no serious issues. At present this study shows it is ongoing, but not recruiting new participants.

Did the Design of the Rejuvenate and ABGII Contribute to Cobalt Hip Poisoning?

At the time the two Stryker designs were released, they were considered cutting edge as far as the innovation of the design. Offering a variety of necks and stems allowed surgeons to more closely match the implant to the patient’s individual size as well as their activity level. The titanium stem was believed to be more flexible than the much harder cobalt and chromium, adding a little “give” at the joint, while the cobalt and chromium neck were believed to be more durable. The Rejuvenate and ABGII were believed to be more stable and were advertised as being extremely long-lasting—maybe even up to twenty years. Because the two models were covered with a proprietary blend of titanium, molybdenum, zirconium and iron mixed with plasma spray, Stryker claimed there would be no corrosion from the dissimilar metals of the titanium stem and cobalt/chromium neck to worry about.

This coating failed to offer the resistance to corrosion Stryker expected, and, in fact, corrosion and fretting were occurring at significantly higher rates at the neck and stem junction. This corrosion caused microscopic metal ions to shear away from the hip implant, entering the bloodstream or the hip tissues. When the cobalt ions entered the hip region, pain as well as destruction and death of the tissue, muscle and bone could occur. Cobalt ions which entered the bloodstream caused metal toxicity among many Stryker patients. Symptoms of cobalt poisoning included: Gastrointestinal, renal, thyroid, cardiovascular and neurological damage, loss of vision and hearing, vertigo, DNA disruption, the formation of pseudo-tumors and issues such as irritability, depression and anxiety.

What did Stryker Know Prior to the Recall of the Rejuvenate and ABGII?

An “Urgent Field Safety Notice” was issued by Stryker in April prior to the recall in July of 2012. This safety notice went to doctors and hospitals—but not to recipients of the implants or consumers considering a Stryker hip implant. The notice admitted to certain flaws, claiming there was a higher-than-normal risk of fretting, corrosion and metal debris. Stryker went on to say that such things as the patient’s weight, whether the patient suffered from diabetes or had an infection, and the patient’s sensitivity to metals could all be responsible for a failed hip implant. They further stated that in some cases the neck pieces had not been adequately cleaned and that there were deficiencies in the locking and assembly of the tapers. It is unclear at this point exactly how much Stryker knew regarding the dangers of the Rejuvenate and ABGII prior to the recall. It is expected that this will be an issue in the pending Stryker Rejuvenate hip recall lawsuits as well as future lawsuits which are filed against Stryker.

Why Blood Testing is Crucial to Detect Metal Toxicity In Patients with Stryker Hip Implants

Metal hip implant recipients are likely very aware of the problems associated with the cobalt and chromium parts of the implant devices. The Stryker Rejuvenate and ABG II, both recalled in July, 2012, are not true metal-on-metal hip implants, but have found to have many of the same risks and dangers. The Rejuvenate and ABG II have a metal neck juncture as well as small metal trundles located on the neck piece. When the two models were recalled Stryker cited the risk of fretting, corrosion and early implant failure.

When the metal parts of the implant corrode, tiny metal particles can shear away from the implant, burrowing into surrounding hip tissues or entering the bloodstream. Metal toxicity can result from cobalt and chromium in the bloodstream and can have very serious consequences. Neurological, cardiovascular, gastrointestinal, renal and thyroid issues have all been found among those with high levels of cobalt and chromium as well as depression, anxiety, irritability, DNA disruption, vertigo, pseudotumor formation, vision and hearing loss and chronic headaches and pain.

There are several tests to measure the levels of cobalt and chromium in the bloodstream, including:

·         Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

·         High-Performance Liquid Chromatography

·         Field-Flow Fractionation (FFF)

·         Isotope/Metal Speciation

The ICP-MS test is faster, more precise and more sensitive than the older atomic absorption tests and is able to detect metal levels as low as one part per trillion. A blood sample from the patient is ionized with inductively coupled plasma. A mass spectrometer then separates the plasma in order to record the levels of metals in the bloodstream. The high-performance liquid chromatography test may be used to test for abnormal levels of cobalt and chromium among those with metal hip implants. Chromatography consists of a mass transfer process which relies on pumps to send the sample of blood through a silica-filled column. This effectively separates the blood components from one another after which a digital microprocessor provides the blood analysis.

FFF uses fluid suspension to separate the blood sample as it is pumped through a long narrow channel. The blood may be sent through an electrical, gravitational, magnetic, centrifugal or thermal-gradient membrane in order to achieve separation. The resulting fractogram identifies the various levels of metals in the bloodstream as well as other species according to physical and chemical properties. Isotope/metal speciation can be used to measure levels of hexavalent chromium in the body. Remember that trivalent chromium is necessary for the normal function of the human body however hexavalent chromium is extremely toxic to the human body, potentially leading to cancer.

The recalled Stryker Rejuvenate and ABG II both have been found to have the potential to send cobalt and chromium into the body, causing a wide variety of adverse health symptoms. Patients who have chronic pain in the hip joint or notice any inflammation in the area should see their physician as soon as possible to undergo blood tests, MRIs and x-rays. Should the hip fail, revision surgery—both riskier and more complex than the original surgery—will be necessary.

When Stryker Rejuvenate and ABGII Hip Implant Patients Develop ALVAL and Metallosis

Patients with metal-on-metal hip implants are likely aware of the issues and recalls surrounding some models. Stryker recalled two of its all-metal hip implants, the Rejuvenate and ABGII in July, 2012. At the time of the recall Stryker declined to comment on the exact failure rate of the implants, however cited fretting, corrosion and the risk of metal debris in the body as reasons for the recall. Metal-on-metal implants were designed with longer wear in mind—the companies claimed from ten to fifteen years. Unfortunately, these claims did not pan out as adverse reports began coming in to the FDA only a short time after the Rejuvenate and ABGII were marketed in 2009.

When the metal parts of the all-metal hip implants rub against one another, there is the potential for metal debris to shear away, traveling through the body. Those metal shards can travel to the surrounding hip tissues or may find their way to the bloodstream. Some patients have been found to have a unique histological response to these all-metal implants termed ALVAL (aseptic lymphocyte dominated vasculitis associated lesion). This hypersensitivity may have a connection to bone dissolution or misalignment of the implant. Any type of misalignment can result in additional wear on specific parts of the implant and this additional wear can cause metal ion generation.

Most of those who suffer from ALVAL cannot complete a straight leg raise without experiencing extreme pain. Fluid aspirated from the hip region of those suspected of having ALVAL is generally thick and greenish-grey in color although there is no infection involved. ALVAL is not completely understood, however when a patient suffers from persistent groin pain yet infection is ruled out, ALVAL may be to blame. Many physicians believe ALVAL is under-diagnosed as the symptoms can be non-specific and systemic. Revision surgery will generally be indicated for patients with ALVAL with a different type of hip implant material.

Metallosis in a patient with an all-metal hip implant occurs when a foreign substance—in this case metal ions produced by friction of the hip implant—enter the tissues of the body. The body’s immune system sends macrophages into the body to fight the metal ions, trapping them and preventing them from spreading. The body is, however, unable to remove metal shards and the result is inflammation, pain, tissue and muscle destruction and death and bone loss. The longer these metal ions remain in the body the more likely the patient is to suffer from a variety of adverse health events.

While it appears some people have a higher tolerance for metal build-up in the body than others, in the end there really are no safe levels of cobalt and chromium in the human body. The longer the cobalt and chromium are allowed to remain in the body the higher the likelihood of a total hip failure, fracturing of the hip bone, severe levels of infection or loosening of the implant—all events which will require revision surgery.  Symptoms of metal poisoning can also occur in Stryker Rejuvenate and ABGII hip implant recipients and can include any of the following:

·         Thyroid and kidney issues

·         Gastrointestinal disorders

·         Cardiovascular and neurological issues

·         Skin disorders

·         Loss of vision and hearing

·         DNA disruption

·         Nerve damage

·         Elevated cancer risks

·         Impaired liver function

·         Reproductive system problems

·         Anxiety, irritability and depression

·         Vertigo

·         Formation of pseudo-tumors

Many of those with significantly elevated metal levels could be symptom-less until the cobalt and chromium levels are extremely high. One orthopedic surgeon, Dr. Antoni Nargol, noted that certain patients with no pain and normal x-rays were found to have “a horrendous amount of metal debris and the cups have been loosened by the metal and the metal debris gets behind the cup…and goes deep into the pelvis and has blown holes in the pelvis.” For this reason, all those with a Rejuvenate or ABGII hip implant should have regular blood testing done in order to monitor the levels of cobalt and chromium in their bloodstream. 

Could an MRI Help Predict Potential Failure of Stryker and Other All-Metal Hip Implants?

The recent rash of metal-on-metal hip device recalls as well as the ensuing lawsuits against manufacturers who appear to have more interest in profits than in patient safety were the topic of discussion at a March 19, 2013 meeting among orthopedic surgeons. This conference, held in Chicago, of the American Academy of Orthopedic Surgeons centered on determining whether judicious use of MRIs could predict soft tissue damage in hip implant recipients before irreparable damage was done.

While the FDA has issued updated guidelines for recipients of all-metal or partial metal hip implants which recommended regular physical exams, blood testing, x-rays and MRIs, many patients are not receiving the MRI test. Any unusual pain and swelling in the hip area following artificial hip implantation is cause for concern and may indicate device failure. Research done on seventy patients who underwent revision surgery for replacement of a defective hip device was discussed by the physicians at the AAOS conference. This research indicated that the superior imaging capabilities of the MRI could more easily identify early tissue damage among implant recipients.

Such early identification can minimize the levels of tissue necrosis and bone loss prior to the revision surgery. When extensive bone and tissue loss is present, revision surgery becomes much riskier for the patient and much more challenging and complex for the orthopedic surgeon. Although metal-on-metal hip implants as well as the designs which implement partial metal components—such as the Stryker Rejuvenate and ABG III—were marketed as providing extended life and greater durability for patients, those promises have not materialized.

Metal implants which were believed to be superior to their ceramic and polyethylene counterparts have been shown to exhibit early failure as well as serious, long-term injuries and illnesses. When microscopic metal ions shear away from the metal components during periods of activity, those tiny cobalt and chromium shards can lodge into surrounding tissues or enter the bloodstream of the patient. Inflammation, chronic pain, tissue necrosis and bone loss as well as symptoms of metal toxicity can occur. Cobalt and chromium toxicity can lead to:

·         Neurological, cardiovascular, renal, thyroid and gastrointestinal disorders

·         Depression, anxiety, irritability

·         Memory loss, vertigo and other balance issues

·         Skin problems

·         Vision and hearing loss

·         DNA disruption

·         The development of pseudotumors

A statement issued at the conference recommended early evaluation for patients with metal hip replacements. Earlier recognition and evaluation of patients with metal hip replacements can allow treatment prior to significant levels of damage to the patient. Specific treatments and diagnostic methods used when patients experience pain and discomfort were also detailed by the AAOS as well as a time frame for beginning treatment and performing revision surgery. The FDA’s updated guidelines have proposed new regulations which would require clinical trials and proof of implant safety prior to marketing hip implants to consumers. This is considered to be a positive step in holding hip implant manufacturers responsible for deficiencies and dangers in their hip devices. The bottom line for those with a metal hip implant is that an MRI can potentially detect tissue and bone damage before it has reached extreme levels. 

What You Should Know About the Recalled Stryker ABG II and Rejuvenate Hip Implant Devices Part One

This is part one of a two-part article regarding the issues surrounding the Stryker Rejuvenate and ABG II hip implant devices. Due to the recent number of defective metal-on-metal hip implants such as DePuy’s ASR, many surgeons placed their trust in a new design introduced by Stryker in 2008 and 2009. The all-metal implants place a cobalt and chromium ball inside a cobalt and chromium acetabular cup; those components rub against one another causing microscopic metal ions to shear away, burrowing into the hip tissue or entering into the bloodstream. 

Stryker’s new design used a ceramic ball with a metal neck juncture as well as small metal trunnions located on either end of the neck piece. The design also boasted four component pieces rather than the usual two which allowed surgeons to choose the individual components based on their patient’s size and level of activity. Surgeons were finally able to custom-fit a hip implant device, using the best angles and lengths for their patients.

Relatively soon after the two Stryker implants were marketed and began being implanted, adverse reports began coming in from patients and the design which was once believed to be the greatest innovation in hip implants found itself issuing a recall in July, 2012. By the time 53,000 Rejuvenate and ABG II implants had been marketed and the majority implanted the recall was issued, stating the risk of fretting and corrosion as well as early failure. Stryker patients were suffering from pain, inflammation and symptoms of metal toxicity. When the neck juncture suffers corrosion toxic metal particles can cause metal toxicity with such symptoms as:

·         Neurological problems

·         Cardiovascular issues

·         Renal and thyroid disorders

·         Loss of vision and hearing

·         The development of potentially dangerous pseudotumors

·         Disruption of DNA

·         Vertigo

·         Anxiety, irritability and depression

When the metal ions become lodged in tissues surrounding the hip joint, inflammation, pain, tissue damage and bone loss can occur, leading to implant failure and the necessity of revision surgery. Stryker issued an Urgent Field Safety Notice to hospitals and physicians in May, 2012. This notice—like the recall notice—stated the risks of the ABG II and Rejuvenate to undergo corrosion, fretting and early implant failure. Many feel the first notice was an attempt to minimize the fear once a recall was issued.

While the ABG II and the Rejuvenate were touted as lasting considerably longer than ceramic and polyethylene implants—even as long as twenty years—many Stryker patients began coming in with such severe problems that revision surgery was necessary after only a few short years. At the time of the recall Stryker stated the failure rate of the ABG II and Rejuvenate as being approximately 12%. It was later discovered that the failure rate may actually be as high as 40% as opposed to the failure rate of a traditional implant of between 4-5%.

The risks of revision surgery—particularly for the Stryker ABG II and Rejuvenate—are higher than the risks of the original surgery and even higher than the risks for other implant revisions. Surgeons dislike performing revision surgery to remove an ABG II or Rejuvenate because of the method of implantation, yet there may be little choice in the matter if a patient begins experiencing symptoms of implant failure or metal toxicity. Part two of this article will more fully detail the surgical procedure for revision of a Stryker ABG II or Rejuvenate hip implant.

How Recipients of Stryker’s Rejuvenate and ABG II Hip Implant Devices Can Get the Help They Need—Part Two

As discussed in part one of this article, many recipients of the Stryker Rejuvenate and ABG II hip implant devices have found their lives turned upside down from adverse health symptoms relating directly to the recalled implants. Although makers of medical devices have a duty to ensure the safety of their products many patients who received all-metal or partial-metal hip implants have found that duty was not upheld. DePuy and Johnson & Johnson are currently embroiled in thousands of lawsuits over their own recalled hip implant and following the July, 2012 recall of the Rejuvenate and ABG II Stryker is beginning to see the lawsuits against their own company mount.

Less than five years elapsed between the time Stryker began marketing these two implants and the time of the recall. Many believe that greed is a factor related to the time which passes between the first adverse reports from patients about an implant and the eventual recall. Over 53,000 Stryker ABG II and Rejuvenates were sold, and it is thought that most of those were likely implanted although the United States does not maintain a hip implant database.

While all revision surgeries are considered riskier and more complex than the original hip implant surgery, there are particular risks associated with the Rejuvenate and ABG II. The stem of these devices is implanted deeply into the femur, therefore when it must be removed the process is fraught with potential problems. The surgical procedure itself takes from 4-5 hours which increases the likelihood of excess bleeding, damage to the nerves, infection and patient mortality. In fact, the mortality risk for a Rejuvenate or ABG II revision surgery is as high as 2.5% compared to less than 1% mortality risk for the original surgery.

In many cases the stem of the Rejuvenate and ABG II must literally be pried loose and dug out of the femur which can result in shattering of the femoral bone. Should this occur, the patient must be sent home in a wheelchair in the hopes that the bone will re-grow and a new implant can be placed in the hip. Some patients end up in a wheelchair for an extended period of time—or even for the rest of their life following a revision surgery for these recalled Stryker hip implant devices.

The recovery time following a Rejuvenate or ABG II revision surgery is significantly longer than the original recovery time—as long as six weeks. Dislocation is an issue which causes physical therapy to be much slower. Lost wages and medical expenses can be overwhelming for the patient and everyday tasks may become impossible. The FDA is in the process of looking at the current application process for artificial hips following the huge number of medical problems suffered by those with these devices. While the present system requires only that the device be substantially similar to another device on the market, new requirements would make clinical trials mandatory and patient safety would move to the forefront above financial gain for the hip manufacturers.

The FDA has also mandated that surgeons should carefully weigh the risks vs. benefits before recommending a metal hip implant to their patients. The patients should be given all information regarding the implant and should understand the risks involved. Patients who have a Stryker Rejuvenate or ABG II implant should make an appointment with their physician in order to undergo testing for metal levels as well as x-rays and an MRI. Even those patients who have suffered no ill effects from their hip implant should see a doctor to determine their risk for future issues. It can be wise to seek legal help as well; if you have already suffered from a recalled implant you are entitled to compensation for your medical expenses and lost wages. Because of the statute of limitations involved in product liability cases, if you have not yet experienced medical problems due to your implant it can still be a good idea to consult an attorney. 

Possible Consolidation of Stryker Rejuvenate Hip Implant Lawsuits

Andrew Sullo, Managing Partner of Sullo & Sullo, LLP, plans to attend a meeting held in Chicago on May 30, 2013, at which time oral arguments regarding a motion to consolidate Stryker Rejuvenate hip implant lawsuits will be heard. The motion filed in February, 2013, seeks to consolidate federal lawsuits against Stryker Orthopedics for alleged harm done to patients by the company’s Rejuvenate and ABG II hip implants. Multi-county and multi-district lawsuits are used to better manage similar cases; resources are conserved when a single court handles all discovery and pre-trial proceedings.

Plaintiffs can have their cases heard in a timely manner when case consolidation takes place and it is generally felt that more consistent rulings result from multi-district and multi-county case consolidation. Further, an already overburdened court system is generally saved both time and financial resources. Over thirty Stryker Rejuvenate cases are currently pending throughout at least a dozen Minnesota district courts, therefore the consolidation of these lawsuits makes sense. Robert Davis, a plaintiff in the Stryker cases filed the consolidation motion, requesting that litigation against Stryker for the harm suffered by recipients of the Rejuvenate be transferred to a U.S. District Court in the District of Minnesota.

Both the Rejuvenate and ABG II were marketed in 2009 after gaining FDA approval. At that time metal-on-metal hip devices had come under scrutiny for the tiny metal ions which were released when the cobalt and chromium parts rubbed against one another. Those metal shards had been found to wreak havoc in the body, causing inflammation, pain, bone loss, tissue degradation and total hip failure as well as metal toxicity. The Rejuvenate and ABG II were believed to be a viable alternative to the all-metal implants as their modular pieces made them extremely customizable. Surgeons could choose the individual parts which comprised the hip implant device in order to custom fit the implant to the patient, taking into account the patient’s size as well as normal activity levels.

Within a very short period of time, however, recipients of the Rejuvenate and ABG II were sending reports of adverse health effects from the hip devices. In April of 2012, prior to the recall in July, an Urgent Field Safety Notice was released by Stryker warning physicians and hospitals of the risk of corrosion, fretting and metallosis from the implants. When corrosion occurs, tiny metal shards from the metal neck juncture or the metal trunnions on either end of the stem could lodge in the hip tissues or enter the bloodstream of the patient. Should the device fail or the metal toxicity progress to a serious level, revision surgery could be the only option.

The success rate for Rejuvenate and ABG II revision surgery is considerably less than for the original surgery and is considered both risky and complex. The stem of the Rejuvenate is embedded deeply within the femur, therefore when removal is necessary the stem must be literally dug out of the bone. In some cases the femur can shatter leaving nothing to attach the new implant to. Recovery times can be from six weeks to two months, resulting in lost wages as well as astronomical medical expenses.

As many as 53,000 Stryker recalled Rejuvenate and ABG II hip implants were sold and it is believed that the majority of those devices were implanted in patients. Stryker issued a follow-up statement in January, 2013, which warned recipients of these recalled implants to undergo regular testing even if they had not yet experienced any adverse health effects from the device. Although there are relatively few lawsuits filed as of this date, it is believed the numbers will increase significantly within the coming year. Following the recall the number of adverse health effects reported to the FDA has substantially increased as more and more recipients of the devices are suffering from the device.