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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Stryker Rejuvenate and ABGII—Getting the Legal Help You Need

A short time after the FDA approved the Stryker Rejuvenate metal hip implant in June of 2008, adverse reports from recipients of the implant began coming in. The implant remained on the market, and in November of 2009 the FDA approved another Stryker metal hip implant, the ABGII. Both models of the metal hip implants came in under the FDA 510(k) approval process which allows medical devices and drugs to gain approval if the manufacturer can prove they are substantially similar to a device or drug which has already garnered FDA approval. While in theory this process sounds reasonable, in practice, many of these drugs and devices were able to be approved based on prior devices or drugs which also had their own problems.

Problems with the 510(k) Process

In the case of the Stryker Rejuvenate, it gained FDA approval based on being substantially similar to the Wright Profemur—which has made the news because of harm to its recipients. In some cases one defective medical device or drug after another can find their way onto the market—and into the bodies of unsuspecting people who likely believe there doctor would not be able to implant a device into their body unless it were safe. Over 500,000 people in the United States alone have metal hip implants in their body despite the fact that a recent FDA panel met to discuss the merits of the metal-on-metal implant and stated that given the many problems which have surfaced on particular metal implants, there was really no reason for surgeons to continue to implant the metal devices.