Stryker Rejuvenate/ABGII and DePuy ASR Hip Implants: Airport I.D. Card Misidentification

In light of DePuy Orthopedics’ 2010 recall of its ASR hip implant and the more recent 2012 recall issued by Stryker of its Rejuvenate and ABGII hip implants, the need for hip implant recipients to properly identify the exact type of hip replacement device they have has become increasingly more important. The DePuy ASR hip implant was recalled due to findings of elevated Chromium and Cobalt levels, blood toxicity, metallosis, and other medical issues in implant recipients. The Stryker Rejuvenate and ABGII hip implants were recalled because of the propensity of hardware components to corrode, resulting in pain and discomfort and other health issues in implant recipients.

Unacceptable Cobalt and Chromium Levels in the Stryker Rejuvenate Hip Implant Patient

Chromium and cobalt toxicity and poisoning are very serious health issues, and those who have an all-metal or partial metal implant should have regular blood tests performed in order to carefully monitor those levels. While those with an all-metal hip implant (such as the Pinnacle or ASR) would likely have much higher levels of cobalt and chromium than those with a Stryker Rejuvenate hip implant, the Rejuvenate revision surgery is much more difficult and risky to the patient. The Rejuvenate is constructed using a ceramic ball, meaning there are not the large metal surfaces of the ball and cup to rub against one another, causing corrosion and metal ions to shear away into the body.

What Makes the Stryker Rejuvenate one of the Most Dangerous Hip Implants on the Market?

It seems that one hip implant after another is being recalled as more and more potential health risks come to light. The Stryker Rejuvenate was recalled in July, 2012 after it was discovered the neck juncture could corrode, leading to the release of metal ions in the body. Prior to the Rejuvenate recall several of the metal-on-metal hip implants suffered their own issues: recalls, adverse reports and lawsuits. When the Stryker Rejuvenate gained FDA approval in June of 2008, it was hailed as a truly innovative as well as much safer alternative to the metal-on-metal implants which were constructed of a cobalt and chromium head and acetabular cup.

Why People are in Pain Following a Stryker Rejuvenate Hip Implant

The Stryker Rejuvenate hip implant was recalled this past July after it was discovered that there was the potential for corrosion at the neck juncture. Corrosion is generally defined as the gradual destruction of materials in this case, human tissue by a chemical reaction within its environment. This corrosion could lead to tiny metal particles shearing away from the implant and lodging in the surrounding tissues or even the bloodstream. Adverse reports began coming in from recipients of the Rejuvenate who were experiencing pain, inflammation and other symptoms related to metal toxicity.

If You Have a Stryker Rejuvenate Recalled Hip But No Pain, What Should You Do?

There is considerable concern among recipients of the Rejuvenate hip implant as well as doctors and orthopedic surgeons who are finding out that the Rejuvenate comes with its own, very specific, set of potential risks. The Rejuvenate is constructed much differently than the original metal-on-metal hip implants before it, therefore doctors may as yet be unaware of the particular issues they should be looking for in their patients.

Stryker Rejuvenate Hip Patients – Why am I in Pain and What are my Options?

Patients who have received a Stryker Rejuvenate hip implant system may be unaware of the July 2012 recall, or may believe that since the Rejuvenate differs in design from the metal-on-metal hip implants we’ve heard so much about that they are relatively safe from harm. Even if those patients are experiencing significant levels of pain, they may believe that pain stems from the aging process or other physical ailments rather than from the Rejuvenate.

When the Stryker Rejuvenate Hip Implant Leads to Cobalt and Chromium Poisoning

Like other hip implant systems before it, the Stryker Rejuvenate was voluntarily recalled in July, 2012. Stryker stated at the time that the Rejuvenate had the potential to cause corrosion and fretting at the neck juncture and that such corrosion could lead to the shearing away of tiny metal particles which could then become lodged in surrounding tissues or enter the bloodstream. The all-metal hip implants have had their share of troubles, as the metal ball and cup would rub against one another during periods of activity, leading to metal ion shear.

Why Diagnosing Problems in Stryker Rejuvenate Hip Implants is So Difficult

When the Stryker Rejuvenate and ABGII were recalled in July of 2012, citing potential risk of fretting and corrosion at the neck juncture, many of the implants had already been removed during revision surgeries. Unfortunately, since most physicians were unaware of the problems with the implants, the operative reports were unlikely to list this corrosion. In other words, since the doctors hadn’t been told what issues to look for, there were few records stating that corrosion was a factor in the revision surgery. When Stryker originally told hospitals and surgeons (in an Urgent Field Safety Report in April of 2012) that there could be corrosion or fretting and release of metal ions, there was still no mention of that corrosion occurring anywhere except at the neck juncture.

Sales Dip for Stryker Following Hip Implant Recalls

Stryker sales have shown a definite dip in the quart since the recall of the Stryker Rejuvenate and ABGII hip implants in July. The hip implant recall came just months after Stryker issued an Urgent Field Safety Notice to hospitals and physicians in April of 2012 citing the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release. Stryker’s hip implant sales dropped nearly 10 percent while its knee implant sales dropped 4.3 percent.

Why the Dip in Revenues?

A Stryker company official stated the recalls of the Rejuvenate and ABGII had only a “modest impact” on the company’s third quarter drop in sales. While the recalls certainly would have impacted Stryker’s revenues, the overall economy may also have played a part. Joint replacement surgical procedures are considered elective most of the time. Those with insurance may delay the surgery to avoid missing work while those without insurance likely cannot afford the procedure. Stryker’s CFO, Curt Hartman also stepped down after two decades at the helm. He reportedly received a 1.5 million dollar separation package although he will remain as an adviser to Stryker through February, 2013.

New Design an Improvement Over Metal-on-Metal Implants?

Metal-on-metal hip implants have been responsible for scores of side effects among recipients. The Rejuvenate garnered FDA approval in 2008 and the ABGII in 2009 and were believed to be not only safer than the all-metal implants but the design was innovative in that the stem and neck were separate parts and were manufactured in a variety of sizes. The surgeon could choose the best size according to the size and activity level of the patient. Because the ball of the Stryker models was ceramic and plastic lined the acetabular cup, it was assumed there would be no metal-on-metal parts rubbing against one another, resulting in metal ions shearing away into the body.

Risk of Metal Ion Release

Unfortunately, the neck portion of the Stryker Rejuvenate is made of cobalt and chromium and even though the ball is ceramic, there is a metal intersection as well as metal trundles at both ends of the neck portion. Body fluids trapped in the trundles can lead to corrosion and the metal intersections can also corrode, sending metal ions into the surrounding tissues or the bloodstream. Although the levels of metal ions in the bloodstream from the Rejuvenate may not reach the level of the all-metal implants, any metal in the body can cause issues for the patient. Those patients who are extremely active have an even greater risk of metallosis, leading to pain, necrosis, infection and failure of the implant. While Stryker’s sales may have taken a dip, it is likely that they will soon have bigger problems as eight lawsuits have already been filed following the Rejuvenate and ABGII hip implant recalls. 

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Consolidation of Stryker Rejuvenate Hip Lawsuits Placed in New Jersey

The state of New Jersey is expected to consolidate at least ten StrykerRejuvenate and ABGII hip implant lawsuits before one judge in order to expedite the handling of these cases. Multi-district and multi-county litigation is described by Class Action Litigation website as a procedure utilized by federal and state courts to transfer all pending cases which are very similar in nature before one judge. This procedure allows lawsuits to move in a more expeditious manner through the discovery phase while still allowing the injured party to seek an individual trial and have their settlement adjusted based on the degree of injury. This is unlike class action lawsuits which dictate that all members share equally in the settlement even though it is unlikely that all injuries would be equal. The first ten cases are coming from Florida, Minnesota, New Jersey and Arizona. Hackensack, NJ was chosen as the consolidation point because it is close to Stryker headquarters. 

Why Patients Aren’t Getting the Message Regarding the Stryker Rejuvenate and ABGII Recall

Despite a Stryker Orthopedics recall in July of 2012 for the company’s Rejuvenate and ABGII hip implant devices, recipients of the devices are simply not getting the information they need about potential implant hazards. Canada, who appears to be a bit ahead of the curve when removing potentially dangerous medical devices and drugs from the market, experienced a recall of the implants almost two months earlier. An Urgent Safety alert was sent out by Stryker to physicians and hospitals in April of 2012, advising that there could be potential problems with the hip implants.

This Safety Alert stated that the potential hazards of the Rejuvenate and ABGII include: “Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space.” Even though Stryker is aware of the potential safety risks of these two hip implants and issued a voluntary recall, they have yet to create a specific program which will both identify those with a Rejuvenate and ABGII as well as aid hip implant recipients in getting the help they need.

Should Stryker Follow DePuy’s Lead for Their Recalled Hip Implants? 

Although Johnson & Johnson announced a method which would allow DePuy ASR victims to get assistance shortly after the recall was issued, Stryker has yet to follow up with similar help for their implant recipients. Johnson & Johnson and its subsidiary, DePuy, hired a third party – Broadspire Services, Inc. - to administer patient claims associated with the ASR recall. Broadspire generally manages workers compensation and other medical claims on behalf of insurance companies and employers, so many were surprised that DePuy and Johnson & Johnson had chosen this route.

Nonetheless, recipients of the ASR felt like DePuy was at least doing something to help them get the treatment they needed while recipients of the Rejuvenate and ABGII have received nothing at this point. The process of physician notification can be laborious and slow which means that a fair number of the estimated 30,000 – 50,000 recipients of the Rejuvenate and ABGII have yet to receive notification of the potential risks of their hip implant.

Dangerous Potential Complications When Recipients of the Stryker Rejuvenate and ABGII Undergo Revision Surgery

Following the recall of the Stryker Rejuvenate and ABGII hip implants in July of this year, physicians are still attempting to notify all those who received one of these implants about the potential hazards. Stryker Orthopedics sent out an Urgent Safety Notice to hospitals and physicians regarding these two hip implants in April prior to the recall in July. Canada recalled the two hip implant devices in May, soon after the safety notice went out. It is fairly likely that many of those recipients of the Rejuvenate or ABGII are as yet unaware of the recall due to the process involved in notifying all patients.

Potential Hazards of the Rejuvenate and ABGII

Marketing data states that there are between 30,000 and 50,000 recipients of the Stryker Rejuvenate and ABGII hip implants across the globe. In their safety letter Stryker noted that the potential hazards of these implants included fretting, corrosion and “excessive metal debris and/or ion generation.”  In fact, many Rejuvenate and ABGII patients began experiencing adverse health effects soon after their implant surgery. Some of the more common negative health effects include inflammation, hip or groin pain, popping or creaking noises, failure of the hip due to tissue damage or metal toxicity which comes with its own set of negative health symptoms. Other recipients of the Rejuvenate or ABGII experienced no negative symptoms for a year, two years, or even more and some patients have yet to experience adverse health effects.

The Likelihood of Negative Health Effects

Unfortunately, statistically speaking, a fair number of those who have not yet had negative health effects may see those effects in the future.  In other words, the likelihood that the hip will fail, inflammation or pain will set in or metal toxicity will occur is much greater than originally believed. This is seriously bad news for all the patients who put their trust in a product that was supposed to be safe for implantation into their body. When metal hips fail or there are symptoms of metal toxicity, revision surgery could be the only option. As many as 50,000 people in the U.S. alone will be required to go through revision surgery due to a failed hip implant.

Stryker Rejuvenate and Stryker ABGII Hip Implant Revision Surgery: Few Good Choices Available

The July, 2012 recall of the Stryker Rejuvenate and ABGII hip implant devices followed an Urgent Safety Alert which Stryker Orthopedics issued in April, 2012. The alert went out to physicians and hospitals which then had the burden of notifying all the recipients of the implants. Because there are between 30,000 and 50,000 worldwide recipients of the Rejuvenate and ABGII, the process of notifying each implant patient may end up being very slow and laborious. This means that there could be thousands of implant recipients who are unaware that their hip implant has been recalled.

The Potential Risks of the Stryker Implants

Stryker’s safety alert admitted that these particular two metal implants could have certain potential risks. These risks primarily include fretting and corrosion as well as metal toxicity when the cobalt and chromium parts of the implant rub against one another during periods of activity, shearing off tiny metal ions. These microscopic shards can become lodged in the surrounding tissue causing pain, inflammation, tissue damage and total failure of the implant. The ions can also travel to the bloodstream causing many adverse health issues including cardiovascular, neurological, renal and thyroid problems as well as DNA disruption.

When Recipients of the Stryker Rejuvenate and Stryker ABGII Hip Implant Develop Pseudotumors

While the term “pseudo tumor” was first used in reference to neurological tumors, the advent of the metal hip implant has expanded the use of the term to describe a generally non-infectious, non-cancerous, space-occupying tumor in the hip region. Metal hip implants have suffered heavily in the past couple of years with recalls, safety concerns and lawsuits abounding. The National Joint Registry of England and Wales indicated that one out of every eight patients who had received the recalled DePuy ASR system were required to undergo revision surgery within five years due to adverse health issues. Stryker Orthopedics has experienced its own troubles regarding their Rejuvenate and ABGII hip implant devices, with both of those implants being recalled in July, 2012. Stryker sent out an Urgent Safety Alert to physicians and hospitals earlier in April of 2012, and issued a recall in Canada in May—proving once again that Canada appears to routinely be ahead of the curve regarding potentially harmful medical devices and drugs.

Do Metal-on-Metal Hip Implants Lead to Pseudo Tumors?

The safety alert issued by Stryker made no mention of pseudo tumors however PR Web states that recent research reveals that those “who have received large-diameter metal-on-metal hip implants…may face a significant risk of developing pseudo tumors.” The article goes on to say that research done in the Netherlands found “recipients of metal-on-metal hip implants had a four times increased risk of developing a pseudo tumor if they presented with elevated serum metal ion levels.” Pseudo tumors which are seen in recipients of a metal hip implant are thought to be a hypersensitive reaction to microscopic metal shards and, generally speaking, patients who develop pseudo tumors must undergo surgery to replace the metal hip device with a ceramic or polyethylene device. In fact, Andrew Sullo, Managing Partner of Sullo & Sullo, a products liability law firm based in Houston, Texas, believes that evidence of a pseudo tumor plus pain may generally equal the necessity of revision surgery.

Preserving Your Right to a Stryker Hip Implant Lawsuit

If you or a loved one is the recipient of a Stryker ABGII or Stryker Rejuvenate hip implant device it is very important that you preserve your health, your future and your right to recovery. Between the time the devices received approval and hit the market (June 2008 and November, 2009) Stryker received reports of health and safety risks regarding the Rejuvenate and the ABGII. Surgeons across the United States submitted reports which voiced concern for the amount of corrosion and fretting seen in the devices which had been removed from their patients, with one surgeon stating it looked like “black rust” around the modular neck junction.

The April 2012 Urgent Safety Bulletin

In a safety bulletin sent to surgeons and hospitals in April of 2012, Stryker noted that excessive metal debris and ion generation were commonly seen in these Stryker hip implant models. Further, high levels of corrosion and fretting were resulting from the metal ion generation, leading to early failure of the device and the necessity of revision surgery. In this safety bulletin Stryker noted that a certain ph level in some patients caused them to be at a greater risk of harm. Further, they stated that tapers which were not adequately locked or sufficiently cleaned could lead to an increase in metal debris generation.

How the Rejuvenate and ABGII Gained FDA Approval 

Both the Stryker Rejuvenate and the ABGII received FDA approval through a process known as the 510(k). This process allows medical devices and drugs to skip clinical trials by asserting they are substantially similar to a device or drug which has already been approved. Of course the drug or device they are claiming to be similar to could have gained approval in the same way. In this particular case, the Wright Profemur was the device the Rejuvenate claimed to be substantially similar to, and the Profemur has had its share of adverse events among its recipients as well. This process causes unsuspecting patients to become guinea pigs as the manufacturer really has no idea whether or not the device or drug is truly safe. Most of us expect that our surgeons will not implant an unsafe device into our bodies, and most surgeons expect that an FDA approved device or drug can be considered safe. Unfortunately this is not always the case, and the metal-on-metal hip implants have had more than their share of troubles.

Don’t Lose Your Right to File a Claim against Stryker

It is believed that over half a million Americans currently have a metal-on-metal hip implant in their body which is, in some ways, akin to a ticking time bomb. When the metal ions shear away from the device they become lodged in the surrounding tissue and cause pain and inflammation or they make their way to the bloodstream where they can eventually cause metal toxicity. The symptoms of metal toxicity may lay dormant for as long as several years and if the patient has not preserved his or her right to recovery—by speaking to an experienced Stryker hip recall attorney—they could find themselves with damaged health and a mountain of medical bills following revision surgery.

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Safety Warnings Regarding Stryker Rejuvenate and ABGII

Just this last April Stryker Orthopedics issued a safety bulletin to doctors and hospitals regarding two hip implants, the Rejuvenate and the ABGII. The bulletin listed the potential for excessive metal debris and metal ion generation in these hip implants, stating this could lead to extreme levels of fretting and corrosion of the hip implant. When fretting and corrosion occur in hip implants, the patient will usually have to undergo revision surgery which is both risky and complex. Additionally, when the metal ions which have been generated from the hip implant shear away from the device, they may either become lodged in the surrounding tissues or can enter the bloodstream. Either of these can cause serious health issues for the implant recipient.

Other Issues Related to the Safety Bulletin

Further, patients who have a heightened sensitivity to these metal ions could have an allergic reaction which causes the tissue surrounding the hip to become inflamed and painful. Stryker listed certain factors which could increase the risk of the metal ions including femoral offset, ph factors of the individual, excess weight of the implant recipient and patient diabetes or infection. When the femoral has too much offset, there will be greater bending motions at the taper junction as well as between the neck and stem.

Is Your Safety Being Ignored in the Approval of Medical Devices and Drugs?

While the FDA declined to require Stryker, a Michigan-based manufacture of medical devices, to recall their Rejuvenate and ABGII hip implants the company made the decision to issue a voluntary recall this past July. The recall came on the heels of an Urgent Field Safety Notice sent out to surgeons and hospitals in April of 2012. That safety notice acknowledged the possibility of metal toxicity from the hip implants admitting to corrosion and wear at the junction of the metal implants.

Adverse Health Effects from Metal Toxicity

Any time two metal surfaces come into contact with one another, corrosion can occur in the form of tiny metal shards shearing away from the implant and lodging in nearby hip tissue or entering into the bloodstream. Extreme inflammation, chronic and severe pain and destruction or death of the tissue can result from those tiny metal ions. Should the metal shards enter into the bloodstream, metal toxicity can occur. Every person will respond differently to varying levels of toxic metals in the body—while some people may have serious adverse reactions to relatively small amounts of metals in the body, others may not have any overt reactions until the levels are extremely high.

Conventional Hip Implants vs. the Stryker Rejuvenate and ABGII

While more traditional hip implants are made up of only two pieces, Wright Medical was the first to introduce a stem and neck split into two separate pieces rather than one. Stryker Orthopedics soon followed suit with two pieces inserted into one another then the ball portion of the Stryker implant is placed on the end of the neck. While the Stryker hip implant models are not considered true metal-on-metal implants, where the metal stem inserts into the metal neck, there exists a metal-on-metal junction. Once the device is implanted into a patient, this junction receives a tremendous amount of stress and can be subject to friction between the metal parts.  

Less Susceptibility to Hip Fracture a Tradeoff for Tissue Necrosis?

Friction can lead to corrosion at the location where the modular metal neck snaps into the body of the femoral stem. While this particular design may have lessened the patient’s susceptibility to hip fracture, the resulting metal debris can cause tissue necrosis and the formation of pseudotumors.  Both the Rejuvenate and the ABGII offer a variety of stems and necks to allow the surgeon to more fully adjust the hip implant to the individual patient’s body type. The Rejuvenate in particular was oriented to a younger populous as a longer-lasting device which would offer the patient a superior range of motion. Both the Stryker Rejuvenate and the ABGII were touted as offering increased stability as well as more elasticity during the implant procedure.

Both DePuy and Stryker Hip Implant Models May Result in Metal Toxicity

Unfortunately, only a short time after these devices received FDA approval, adverse patient reports began coming in. Once the Rejuvenate and the ABGII were implanted into patients, there were instances where the stem and neck rubbed together causing microscopic metal ions to shear away from the implant into the surrounding tissue or the bloodstream of their recipients.  When those metal shards became lodged into the surrounding hip tissue, destruction or death of the tissue often occurred. Metal toxicity from the metal ions entering the bloodstream were also found to cause significant health problems including cardiovascular, kidney, thyroid and even DNA alterations. Revision surgery became the only option for many of those implanted with a Rejuvenate or ABGII. Unfortunately, this particular revision surgery comes with serious risks since the neck of the device is implanted deeply into the femur. When the implant is removed the patient may be left with very limited mobility due to tissue and bone damage.  

The Process of FDA Approval

The Rejuvenate was granted approval by the FDA in June of 2008 with the ABGII following quickly on its heels, receiving FDA approval in November of 2009. Both of these hip implant devices received approval under the 510(k) process which has been criticized by many as being much too lenient for medical devices and drugs. The 510(k) approval process allows drugs and medical devices to gain FDA approval without the necessity of clinical trials. The drug or device in question must simply be shown to be more or less the same as a device or drug already approved. Demonstration of product safety is not necessarily a requirement of approval under this particular process which means that flaws generally only surface after the devices have been implanted into recipients. Perhaps even worse, the Stryker hip implant appears to have been patterned after a hip implant device which had already demonstrated some adverse health risks. Stryker markets over 57,000 products across the world which generate over $8 billion dollars in revenues for the company.

Differences and Similarities between DePuy and Stryker Implants

The DePuy metal-on-metal hip implant has come under fire due to the metal components which rub against one another during periods of physical activity, causing tiny metal ions to shear off. These ions may lodge into the surrounding tissues or could potentially enter the patient’s bloodstream, either of which can be extremely dangerous. Initially it was believed that because Stryker’s design does not incorporate a metal ball rubbing against a metal socket, it would not be subject to the same types of metal toxicity in its recipients. As it turns out, the neck of the Stryker hip implants are made of cobalt and chromium, the stem is titanium-coated and there is a metal-on-metal junction involved which gives recipients of the Stryker Rejuvenate and Stryker ABGII the risks of metal toxicity.

The Recall

Three months prior to the voluntary recall by Stryker of the Rejuvenate and ABGII, the company issued a safety alert to surgeons and hospital risk management personnel regarding these particular implants. They stated potential hazards of excessive metal debris caused by corrosion and fretting at the modular neck junction. When the actual recall was issued in July, 2012, it is estimated over sixty adverse reports had been received claiming metal toxicity. Those patients could likely be subjected to revision surgery which is very complex and risky due to the fact that the Stryker hip implant goes deeply into the femur. Positive outcomes in these revision surgeries may not be the norm with many Stryker hip implant recipients being left with a diminished range of motion.

If You Are a Stryker Hip Implant Recipient You Must Seek Medical and Legal Advice

Of course the first order of business if you’ve been implanted with a recalled Stryker Rejuvenate or Stryker ABGII is to seek medical advice. See your physician and discuss your implant as well as any health problems you’ve had as a result of the implant. Even if you have not yet suffered adverse health effects from the hip implant, you should still see your doctor. In the same vein, you should also seek qualified legal advice so you will have all the information you need should you decide to file a claim against Stryker within the statute of limitations for your particular state.

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