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.

The Stryker Hip Implant Recall and How It Affected Consumers

The Stryker hip implant recall was yet another among a growing number of metal hip implant recalls seen over the past few years. Recipients of the Rejuvenate and ABGII, were dismayed to hear of the Stryker hip implant recall in July, 2012. Since the two hip implant devices received FDA approval in 2008 and 2009, a significant number of adverse reports from consumers were sent to the FDA. Due to the controversial 510(k) approval process, no clinical trials of the hip implants were required; it was only necessary for Stryker to make a case that the Rejuvenate and ABGII were substantially equivalent to a device already on the market.

As the Stryker hip implant recall demonstrated, this level of approval is likely not sufficient to ensure the safety of consumers. After over sixty reports of ill health effects concerning the Stryker Rejuvenate and ABGII—and over 17,000 reports totalfor all metal hip implants reported between 2000 and 2011—it appeared that it was only a matter of time until the Stryker hip implant recall was put into place. Considering that only a small percentage of recipients will take the time to send a report to the FDA, it is possible the total number of adverse health effects is considerably higher.

At the time of the Stryker hip implant recall, Stryker declined to state the exactfailure rate of the Rejuvenate and ABGII implants. Following the Stryker hip implant recall, independent studies placed the number as high as 40%. This means that even those implant recipients who have not yet experienced ill health from the devices might in the future. The Stryker hip implant recall was instigated due to a higher than normal rate of failure due to fretting and corrosion which lead to the shedding of metal debris into the body.

This metal debris can cause inflammation, infection, chronic pain, implant failure, deterioration of bone and tissue as well as a variety of very serious health symptoms linked to metal poisoning. It is advisable for any recipient of the Rejuvenate or ABGII to have tests which measure cobalt and chromium in the bloodstream done as well as to speak with a knowledgeable Stryker hip implant recall attorney who can assess the individual’s situation and offer plausible options moving forward.

What Preceded the Stryker Hip Recall?

Following the Stryker hip recall there were many patients concerned about the potentially dangerous hip implant that resides in their body. Soon after the Rejuvenate and ABGII gained FDA approval—through the controversial 510(k) program—adverse reports began coming in to the FDA. The Rejuvenate was approved in 2008 and the ABGII in 2009 and were being marketed to surgeons and consumer by 2010. There were no clinical trials done to fully assess the safety of these two implant devices prior to the Stryker hip recall. Although before the Stryker hip recall, the company claimed these new hip devices would last from 15-20 years, some patients who had the implants less than a year suffered serious health problems.

Prior to the United States Stryker hip recall in July, 2012, Health Canada implemented a Stryker hip recall in May, 2012. Stating risks of corrosion and fretting which could lead to excess metal debris being released in the body, the Stryker hip recall left many patients feeling angry and frightened.  Since the Stryker hip recall, it was found that the Stryker hip implants were constructed using metal trunnions on either end of the neck piece. Those metal trunnions allowed body fluids to become trapped beneath, leading to further corrosion. Inflammation, infection and chronic pain resulted from that corrosion in many patients, causing deterioration of tissue and bone and the necessity of a revision surgery.

The Stryker recall also mentioned metal toxicity which occurs when the metal debris enters the bloodstream, causing such issues as: gastrointestinal disorders, neurological and cardiovascular problems, renal and thyroid issues, loss of hearing and vision, disruption of DNA, pseudo-tumor development, anxiety, irritability, memory loss, depression, vertigo and reproductive disorders. Following the Stryker hip recall, Stryker has claimed that excess weight, a history of diabetes, the patient’s ph levels, incorrect implantation techniques and patient infection could all contribute to medical issues. The implication is that the Stryker hip recall was merely a precaution rather than the serious medical issue it really is.

How Stryker Corrosion Attorneys Help Victims of Recalled Hip Implants

Across the United States, scores of Stryker corrosion attorneys have been working hard to help those harmed by the recalled Stryker Rejuvenate and ABGII hip implants. The devices were recalled in July, 2012, after many adverse reports regarding the two Stryker implants came in to the FDA. The stated reason for the recall was the threat of fretting and corrosion, leading to excess metal debris and a higher-than-normal rate of failure. Stryker corrosion attorneys have spoken with many recipients of these dangerous hip implants, and have worked hard to ensure they fully understand the issues surrounding the recalled devices.

Because the ABGII and the Rejuvenate are not “true” metal-on-metal hip implants, due to the ceramic ball, it was believed they were much safer than the all-metal hip implant devices. Unfortunately, as Stryker corrosion lawyers have seen, this belief turned out to be untrue. The design of the Rejuvenate and ABGII were considered extremely innovative as they offered surgeons a wide array of different-sized components. This meant that surgeons could fit the implant more precisely to the individual patient, taking into consideration the patient’s body size and level of activity.

Some Stryker corrosion lawyers have actually seen a recalled Stryker implant which has been removed from a patient after the implant failed. The explant—in many cases—shows black corrosion which could have spread to the hip tissue as well. When metal debris shears away from the hip implant, once corrosion occurs, those cobalt and chromium ions may become lodged in the hip tissue or enter the bloodstream. After speaking to many injured patients, Stryker corrosion lawyers understand that inflammation, chronic pain, infection, bone loss or destruction and tissue degradation are all possible.

The patients who suffer metal poisoning when the ions enter the bloodstream can suffer such serious issues as loss of vision and hearing, DNA disruption, the formation of pseudo-tumors, gastrointestinal, renal, thyroid, cardiovascular and neurological disorders, reproductive disorders, memory loss, irritability, depression and anxiety. Zealous Stryker corrosion attorneys strive toward a goal of having all those harmed by a recalled Stryker hip implant compensated for their medical expenses, lost wages and pain and suffering.  

Could Calling a Stryker Hip Lawyer Improve Your Future?

The thousands of patients implanted with a Stryker Rejuvenate or ABGII hip implant device were dismayed when both models were recalled in July, 2012. Only a few short months prior, Stryker sent out an urgent field safety notice to hospitals and surgeons after receiving numerous complaints from implant recipients. As Stryker hip lawyers are aware, the FDA received adverse medical reports regarding these two hip implants almost from the time the devices were approved, in 2008 and 2009. Stryker advertised the new design of the Rejuvenate and ABGII as being a vast improvement over other metal-on-metal implants, as a ceramic ball was used, rather than a metal one.

The Rejuvenate and ABGII also offered surgeons a wide variety of component sizes in order to customize the fit of the implant to the patient’s size and activity level. Stryker hip lawyers immediately educated themselves regarding the design of the Stryker Rejuvenate and ABGII as well as the risks involved to patients. As detailed in the urgent field safety notice, the Rejuvenate and ABGII had a higher-than-normal rate of failure due to the propensity for corrosion and fretting. When corrosion occurred in the devices, tiny metal ions sheared away, burrowing into the surrounding hip tissue or entering the bloodstream.

Many Stryker hip implant recipients discussed with their Stryker hip lawyer the fact that they suffered chronic pain, inflammation and infection as a result of those metal ions. Even more alarming, once the inflammation reached a certain level, bone and tissue would begin to deteriorate. In the most severe cases, the tissue would die and the bone would disintegrate, leading to total failure of the hip implant. Stryker hip lawyers understand the problems associated with revision surgery, once hip failure occurs. Because of the design of the Rejuvenate and ABGII, the stem portion is implanted deeply into the femur. When surgeons must remove the stem from a bone which is already compromised, the bone can shatter, making revision surgery impossible and the necessity for a Stryker hip lawyer likely. Patients further detailed symptoms of metal poisoning to their Stryker hip lawyer which included:

·         Gastrointestinal, neurological, renal, thyroid and cardiovascular disorders

·         Hearing and vision loss

·         DNA disruption

·         The development of pseudo-tumors

·         Reproductive disorders

·         Memory loss

·         Irritability, depression and anxiety

Many of those harmed by the recalled Stryker hip implant devices have found considerable relief from being able to turn over their worries regarding their implant to an experienced, responsible Stryker hip lawyer.