Speaking With a Stryker Hip Attorney Could Improve Your Future

Patients who received a Stryker Rejuvenate or ABGII hip implant were likely dismayed to hear in July, 2012, that both models had been recalled. Stryker hip attorneys received hundreds of phone calls from frightened and angry implant recipients. After all, these patients had been assured that the Stryker hip implants were perfectly safe. Along with Stryker hip attorneys, most surgeons believed the new Stryker implant models were much safer than the “true” metal-on-metal implants due to the ceramic ball.

Unfortunately, a significant number of patients began having serious health problems following their Stryker hip implant surgery. After a number of these issues were reported to the FDA, Stryker hip attorneys watched carefully to determine whether a recall would follow. While Stryker issued an urgent field safety notice to hospitals and surgeons in April of 2012, the recall did not come until a few months later. Stryker stated the reason for the recall was a higher-than-normal risk of implant failure due to excess metal debris resulting from fretting and corrosion.

As any experienced Stryker hip attorney knows, these tiny metal ions can wreak havoc in the human body. When the ions lodge in hip tissues, pain, inflammation, tissue and bone deterioration and total hip failure can result. Stryker hip attorneys have a clear understanding of these symptoms as well as those resulting when the metal ions enter the bloodstream.  Cobalt and chromium ions in the bloodstream can result in many adverse health symptoms, including the development of pseudo-tumors, disruption of DNA, loss of hearing and vision, neurological, thyroid, renal, gastrointestinal and cardiovascular disorders and a litany of lesser—yet still serious—symptoms.

Stryker hip attorneys also heard from many patients who were forced to undergo revision surgery which is both risky and expensive. Revision surgery resulted in many patients being off work for as long as six weeks. Patients who spoke with a Stryker hip attorney found that with an aggressive advocate by their side, it was possible to pursue compensation for lost wages, medical expenses and pain and suffering. Stryker hip attorneys can help ensure that deadlines are not missed and can also thoroughly assess each individual situation in order to determine the best course of action.

Patients Who Experience Stryker Metal on Metal Poisoning Symptoms

Stryker metal on metal poisoning symptoms can occur when an accumulation of metal debris in the bloodstream of the body takes place due to defective metal hip implant devices. Stryker’s Rejuvenate and ABGII were recalled in July, 2012, after scores of patients reported experiencing Stryker metal on metal poisoning symptoms. Stryker stated the two hip implant devices were recalled due to fretting and corrosion leading to excess metal debris and hip failure. Although Stryker did not mention the actual rate of hip failure, many independent studies put that number as high as 40%.

Despite the fact that the Stryker recalled hip implants utilized a ceramic ball, rather than a metal one, corrosion was found to occur at the junction between the titanium stem and the cobalt and chromium neck. Corrosion was also found to occur beneath the small metal trunnions located at either end of the neck portion. These areas of corrosion were responsible for tiny metal particles shearing away from the implant, lodging in the surrounding tissue or the bloodstream. The metal ions in the bloodstream are responsible for Stryker metal on metal poisoning symptoms including: cardiovascular issues, loss of hearing and vision, chronic headaches, vertigo and other balance issues, short-term memory loss, neurological problems, including seizures and tremors, reproductive disorders, the development of pseudo-tumors and even disruption of DNA.

Other issues such as anxiety, irritability and depression have also been found to occur in those suffering from Stryker metal on metal poisoning symptoms. Aside from Stryker metal on metal poisoning symptoms, when the metal shards burrow into the hip tissues, inflammation, pain, infection, bone loss and tissue deterioration can occur. When the implant is removed, doctors will typically see a gray discoloration of the tissue surrounding the hip implant, meaning the tissue is starved for oxygen and has begun to die.

Implant recipients who are particularly sensitive to heavy metals are more likely to experience Stryker metal on metal poisoning symptoms than those with a higher tolerance for metals. Although both chromium and cobalt cause considerable damage to the body, cobalt is the more serious of Stryker metal on metal poisoning symptoms. Liver damage and cancer are among the more serious risks of excess cobalt in the body. Those patients who have experienced Stryker metal on metal poisoning symptoms should see their physician and have regular blood tests done to monitor metal levels.

When Patients Develop Stryker Cobalt Toxicity

Any patient with a Stryker Rejuvenate or ABGII hip device implanted in their body can suffer from Stryker cobalt toxicity. Although these two particular models do not implement a metal ball, the use of a metal liner, the metal neck junction and the small metal trunnions located on either end of the neck portion can lead to microscopic cobalt and chromium ions shearing away into the body. When the metal ions lodge in the hip tissues, infection, severe inflammation, bone and tissue loss and chronic pain can occur in the implant recipient.

Stryker cobalt toxicity can occur when those particles reach the bloodstream, causing a number of very serious health issues. Cobalt is not an accumulating metal; it resides in the liver where it is processed out through urine output in those with fully functioning livers. This means that in most cases, when the implant is removed, through revision surgery, the dangerous levels of cobalt should subside, and the symptoms of Stryker cobalt toxicity should lessen. Stryker cobalt toxicity can cause such symptoms as irregularities of the heart, certain types of cancers, chronic headaches, vision and hearing loss, irritability, depression, anxiety, renal and thyroid disorders, gastrointestinal disorders, disruption of DNA and the formation of pseudo-tumors.

Stryker cobalt toxicity is a serious concern among those with a Stryker Rejuvenate or ABGII recalled implant. Recipients of the hip devices may wonder what the safe levels of cobalt truly are.  While some scientists believe the levels of cobalt are not harmful until they reach over 7 parts per million, others believe that anything over 3 parts per million can result in Stryker cobalt toxicity and the need for revision surgery. Further, some implant recipients are more sensitive to heavy metals and, while they may test relatively low for cobalt levels, the patient may have serious Stryker cobalt toxicity symptoms. Others with higher cobalt levels may have not yet experienced Stryker cobalt toxicity symptoms.

Another source of Stryker cobalt toxicity may be linked to the fact that the titanium-coated stem does not mix well with the cobalt and chromium neck piece, leading to excessive corrosion where the two metals meet. Even though Stryker sprayed the pieces with a proprietary formula meant to “cure” the issues regarding mixed alloys, excessive corrosion has been found time after time at the junction where the metals meet. Any Stryker cobalt toxicity symptoms should be reported promptly to a physician, and regular blood tests should be done to monitor the levels of cobalt and chromium.

The Problems Associated With the Recalled Stryker Rejuvenate

Like the Stryker ABGII, the Stryker Rejuvenate was recalled over a year ago, in July, 2012. At the time of the recall, Stryker officials stated the Stryker Rejuvenate had a higher-than-normal rate of failure due to corrosion and fretting, leading to metal ion debris being released into the bodies of patients. Stryker chose to use a ceramic ball in the Stryker Rejuvenate rather than a cobalt and chromium ball as well as creating a dual modularity design for the Stryker Rejuvenate. The design features of the Stryker Rejuvenate allowed surgeons to custom fit each hip implant device to the individual patient’s body type and activity level.

The Stryker Rejuvenate was geared toward younger, more active patients, and most of the thousands of patients who received a Stryker Rejuvenate believed it to be a safer alternative to the all-metal hip implant devices. Unfortunately those beliefs were shattered when patients began seeing adverse health symptoms soon after they received their Stryker Rejuvenate implant. A combination of issues in the Stryker Rejuvenate worked together to create a potentially dangerous hip implant device. The longer stem of the Stryker Rejuvenate made it more difficult to remove should a revision become necessary. The coating on the implant was thick and particularly porous, to encourage the bone to grow into the implant, once again making it more difficult to remove.

A serious mismatch between the titanium stem portion and the cobalt and chromium neck could also be responsible for the extremely high levels of metal ions released in Stryker Rejuvenate patients. Studies done over a decade ago found corrosion to be significantly higher in hip implants—such as the Stryker Rejuvenate—which used dissimilar metals. A more recent study noted that a galvanic reaction occurred when the titanium stem and chromium and cobalt adapter sleeve of the Stryker Rejuvenate were mixed. Researchers believe that galvanic reaction occurs due to the harder cobalt and chromium metals.

Patients who have a Stryker Rejuvenate hip device implanted in their body should be alert for any adverse health effects; metal toxicity can cause a variety of symptoms such as loss of hearing and vision, vertigo, depression, anxiety and irritability, skin disorders, DNA disruption, cardiovascular, neurological, gastrointestinal, renal and thyroid disorders, some forms of cancer, reproductive issues and loss of memory.

The Causes of the Stryker Recall

A little over a year ago, in July, 2012, a Stryker recall was issued for the Rejuvenate and ABGII hip implant devices. These implants fell under a Stryker recall due to the risks of fretting and corrosion which could lead to the release of metal ions into the body and failure of the hip implant. When a hip implant fails, revision surgery becomes necessary—an expensive and potentially risky procedure. Nearly 20,000 people were implanted with a Rejuvenate or ABGII hip device prior to the Stryker recall. These people hoped to have the quality of their life improved through being able to achieve greater mobility. When the Stryker recall was issued, the hopes of many of those people were dashed.

Of course prior to the Stryker recall, many recipients had already suffered serious adverse health effects from their Stryker hip. Stryker advertised this innovative new design as potentially lasting 15-20 years, saving many people from ever having to have their hip implant replaced. Unfortunately, following the Stryker recall, most recipients realized they would likely not have their Stryker hip implant anywhere close to that long. In fact, at the time of the Stryker recall, the company refused to put a number on the risk of failure, but later, independent studies placed that risk as high as 40%.  What this meant for those subject to the Stryker recall, is that those patients who had not yet had trouble with their implant likely would in the near future.

Although the Stryker recall lumped the two hip devices together, there are some differences. The ABGII has a shorter stem, and is covered with a shallower layer of hydroxyapatite porous coating, making it somewhat easier to remove than the Rejuvenate. The neck piece of both models is constructed of cobalt and chromium and the stem is titanium, however the metals are in slightly different proportions. The Stryker recall meant that many implant recipients were forced to see their doctor to have their levels of cobalt and chromium tested as well as to speak to a Stryker recall attorney to explore future options. After all, the Stryker recall caused many patients to be left with huge medical expenses and lost wages from being unable to return to work. Many of these patients suffered substantial amounts of chronic pain, as well as significant levels of emotional suffering. The Stryker recall is likely to have long-term repercussions for many recipients of a Rejuvenate or ABGII.

What Type of Stryker Rejuvenate Design Problems Were Present?

Stryker Orthopedics, a Michigan-based corporation, recalled the Rejuvenate, a metal hip implant device, in July, 2012. The recall came on the heels of an Urgent Field Safety Notification sent to hospitals and surgeons in April. Stryker stated a risk of fretting and corrosion in the Rejuvenate which could potentially lead to excess metal debris being released into the body. With over 9,000 Rejuvenate hip devices implanted in consumers, those risks may have serious, far-reaching repercussions.  The Rejuvenate garnered FDA approval in 2008, only a few short years prior to the recall.

Was the FDA Aware of Stryker Rejuvenate Design Problems?

The process under which the Rejuvenate was approved has come under fire over the past few years: the 510(k) process allows medical devices to be approved based on their similarity to a device already on the market. In the case of the Rejuvenate, approval was gained based on the Wright Profemur Total Hip System which was, itself, based on yet another hip implant device. The fact that these hip implants may also have had problems of their own apparently has little bearing on new approvals. The Rejuvenate and the Profemur do share one design similarity: they both use interchangeable titanium neck components. The 510(k) process also allows manufacturers to circumvent the normal requirements of clinical trials as well as skipping important safety testing.

Stryker Rejuvenate Defects

While the majority of the focus has been on all-metal hip implants, and the Rejuvenate implements a ceramic ball, it appears the same problems exist in the Rejuvenate as with the all-metal implants. In fact, the Stryker Rejuvenate may have the same level of risk of metallosis and metal toxicity as the recalled metal-on-metal hip implants. While Stryker has declined to put a number on the failure rate of the recalled Rejuvenate, independent studies place that number as high as 40%, despite the use of a ceramic ball.

Metal toxicity can occur when the metal components of the hip device rub against one another during normal physical activity. In the case of the Rejuvenate, the titanium stem rubs against the cobalt and chromium neck piece at the junction between the two, causing small metal ions to shear away and enter the body. Further, the Rejuvenate implements tiny metal trunnions located on either end of the neck piece which can also cause corrosion when body fluids become trapped underneath.

What is Wrong with the Stryker Rejuvenate?

Symptoms of metal toxicity include gastrointestinal disorders, cardiovascular and neurological disorders, renal and thyroid problems, loss of hearing and vision, disruption of DNA, the development of pseudo-tumors, the increase in certain types of cancer, vertigo, memory loss, depression, anxiety and irritability. When the tiny metal ions enter the surrounding hip tissue, infection, inflammation, chronic pain and the deterioration of bone and tissue can occur, leading to total failure of the hip implant. Because the Rejuvenate stem component is placed so deeply within the femur bone, should hip revision become necessary, removing the stem can be difficult, dangerous and costly.

What About Stryker Rejuvenate Mismatched Components?

Among the many problems associated with the Rejuvenate, it appears that mismatched components may be a major issue. Despite studies done years before, stating the dangers of mismatched components, Stryker chose to pair a titanium stem with a cobalt and chromium neck.

Hoping to alleviate some of the known risks, Stryker used a hydroxyapatite porous coating—which they expected to minimize the negative interaction between the dissimilar metals—however the coating failed to deliver. One study in particular noted that while moderate to severe corrosion was seen in approximately 28% of similar alloy hip implant components, that number rose to over 42% when mixed alloys were used. Scientists are not certain what causes the metal ion shear in mismatched components, but believe it is related to the fact that cobalt and chromium are considerably harder than titanium.

In looking at hip components removed during revision surgery, those implants which did not mix metals showed no evidence of corrosion, while the implants which used mismatched metal components showed significant levels of corrosion. Galvanic corrosion is the term used to describe the electrochemical differences between two dissimilar metals; in scientific terms the anode, or active metal is attacked by the cathode, or more resistant metal. Some metals will form a stable passivation field once they are implanted in the body, however research has shown that this field is only present and protective when there is no motion and no wear of the implant. The cobalt chromium alloy has a hardness factor of 4.5 GPa (Gigapascal—1 GPa = 140,000 psi) while the titanium alloy has a hardness factor of 3.0 GPa, meaning the cobalt and chromium component is less susceptible to galling, and, overall, more resistant to fretting and corrosion than the titanium component. 

Were Stryker Rejuvenate Defects Known Once the Devices Began Being Implanted?

The question many consumers have is whether Stryker was aware of the problems associated with the Rejuvenate long before the recall? Why did the manufacturer choose to use mismatched components in the Rejuvenate despite scientific evidence proving there were problems associated with mixed alloys? Perhaps one reason Stryker used a titanium stem component due to the higher modulus of elasticity as compared to human bone in the cobalt and chromium components.

The titanium stem was also found to be more fatigue-resistant and easier for the manufacturer to shape into the proper design. Finally, the titanium components allowed for more bone ingrowth—thought to be a positive aspect which would allow the hip implant to gain stability. Unfortunately, should the Rejuvenate require removal, it can be extremely difficult due to this bone ingrowth. As the number of lawsuits against Stryker continues to grow, the question of whether Stryker Rejuvenate defects were known prior to marketing is likely to surface.