Stryker Orthopaedics recently recalled two of its modular hip devices due to an increased risk of metallosis and tissue damage in patients with the Stryker products. New research has demonstrated a link between the Stryker hips and elevated levels of metal particles in the blood and soft tissue of patients, which can lead to necrosis of the tissue surrounding the implanted device. The Stryker hips were also reportedly failing and requiring replacement or revision surgery much earlier than other artificial hips.
After a connection between the Stryker products and soft tissue destruction in patients was also established, Stryker Orthopaedics recalled the existing hip systems and stopped manufacturing these particular modular hip devices. Patients have now started litigating their Stryker hip claims with this new research to support their cases and to counter the previously held belief that metallosis could not occur in ceramic hip products. Until these new findings were released, it was believed that only true metal-on-metal hips could cause metallosis and its related conditions. However it has now been shown that even ceramic hips that use metal-on-metal components can lead to the development of metallosis and soft tissue destruction.
If you or someone you know had one of these recalled Stryker hips implanted, or if you are unsure as to whether a Stryker hip product was used, we encourage you to contact Johnson & Vines so we can assist you with any questions you may have regarding the Stryker hip recall and your rights regarding the same.
Stryker Products Recalled
The two specific metal hips manufactured by Stryker Orthopaedics subject to the July 2012 recall are the “Rejuvenate Modular-Neck Hip Stem” and the “ABG II Modular-Neck Hip Stem”, released to the market in 2007 and 2010 respectively. Therefore, patients who underwent hip replacement surgery before 2007, or after July 2012, are unaffected by the Stryker recall addressed here as neither device would have been used at that time.
Rejuvenate and ABG II Modular Hip Reported Defects
Although the recalled hips are not true “metal-on-metal” hips in that they do not have a metal-on-metal ball and socket design, the Rejuvenate and ABG II Modular hips have now been shown to cause the same conditions as metal-on-metal hips that have repeatedly been the subject of lawsuits over recent years. The Stryker devices were specifically designed with ceramic components to avoid the metal rubbing and corrosion commonly associated with traditional metal-on-metal hips.
The Rejuvenate and ABG II hips were therefore marketed as being safer because of their “ceramic-on-metal” ball and socket designs. Additionally, because the Stryker hips were modular, they were also marketed as being more durable and longer lasting due to their ability to be custom fitted. Accordingly, younger patients requiring hip replacement surgery were frequently advised to use the Stryker modular hip devices. However, even though the Rejuvenate and ABG II devices were designed with a ceramic-on-metal ball and socket, they still used metal modular components for the hips necks and stems. Under certain circumstances, the Stryker metal neck and stem pieces would rub against each other and result in the release of metallic shavings and debris into the surrounding area.
A 2013 study of patients who underwent total hip replacement surgery and received the Stryker Rejuvenate hip established that all patients demonstrated soft tissue injuries due to corrosion at the hip’s metal neck-body junction. Blood tests further revealed the patients all had elevated levels of titanium, chromium and cobalt in their blood, indicating the patients were suffering from metallosis.
Metallosis is characterized by an adverse soft tissue reaction due to the accumulation of heavy metals in the body. The condition can cause pain and swelling, dislocation, and often requires additional surgeries to repair or replace the failing hip. The buildup of metal in the body can also cause tumor-like growths and bone deterioration in and around the affected areas. When severe enough and if left untreated, metal poisoning can ultimately occur causing kidney failure, fatigue, depression and numerous other adverse physical and psychological conditions.
This study demonstrated that while it was previously believed that metallosis could only be caused by metal-on-metal hips because of the constant friction within the ball and socket, other hip designs such as the Rejuvenate and ABG II with metal neck and stem components could also have metal-on-metal rubbing and likewise release metallic debris into patients’ bodies. The new research further revealed an early failure rate that was much higher than advertised for the Stryker hips that were supposed to be much more durable. In some cases, revision surgery was required after only a few years of use.
The Stryker Recall of the Rejuvenate and ABG II Modular Hips
Before voluntarily recalling the Rejuvenate and ABG II Modular Hip devices, Stryker Orthopaedics initially denied that these hips could cause metallosis or that they were otherwise defective in design and causing the issues complained of by patients. In April of 2012, after repeated complaints about the hip systems had been surfacing and in response to claims that the hips were requiring revision surgery much sooner than the typical 15 to 20 year range, Stryker Orthopaedics released a product bulletin on the Rejuvenate Modular Hip. The bulletin provided that any corrosion of implanted parts could be explained by the patients’ health conditions, including diabetes or infections, because the pH levels in their bodies and in the tissue surrounding the implants would be affected by these conditions. They additionally claimed that patients’ failure to properly participate in rehabilitation after surgery was to blame in many cases, and that surgeons had also improperly installed the Stryker hip systems in others cases.
In June of 2012, the Stryker Rejuvenate Modular-Neck Hip Stem and ABG II Modular-Neck Hip Stem were voluntarily pulled off the market by the company. The company officially stated it was recalling the products “due to the potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”
Stryker identified pain and swelling as the symptoms associated with the defective Rejuvenate and ABG II hips. The U.S. Food and Drug Administration has also provided guidance on possible signs of a failing hip implant and noted a hip implant may not be functioning properly if 3 months after surgery, the patient experiences hip, leg or groin pain, there is swelling at or close to the hip, a popping, grinding or clicking sound is heard, or where the patient walks with a limp or has restricted movements. Patients should seek medical attention if they are experiencing any of these symptoms.
The Stryker Hip Lawsuits
As a result of the recent research and subsequent recall of the Stryker hips, it is recommended that any patients with the hips be examined for necrosis in the tissue surrounding their implant and undergo blood testing to determine whether metallosis has developed. The recall has also led to a growing number of Stryker hip lawsuits being filed throughout the country.
Thousands of Rejuvenate or ABG II hip replacement patients have already filed lawsuits against Stryker alleging they have developed metallosis, soft tissue necrosis, and osteolysis due to the defective hips. These patients seek compensation for their medical expenses, lost wages, and their pain/suffering resulting from the recalled Stryker manufactured hips.
The Stryker lawsuits have been consolidated into 2 large multi-district litigation suits: a federal case in Minnesota with approximately 2,300 cases from across the nation and another 2,600 cases have been consolidated in New Jersey. In November of 2014, it was announced in the Minnesota case that the Stryker lawsuits before that court would be settled for a total of approximately $1.4 billion dollars, with injured patients receiving at least $300,000 in compensation.
In New Jersey, where Stryker Orthopaedics U.S. headquarters is based, the suit is also proceeding with the goal that the parties will ultimately reach a settlement and agree on compensation for the patients. The court has ordered the parties to mediate the claims against Stryker for the defective hips and if settlement is not reached, the cases will begin going to trial in June and July of 2015.
If you or your loved one has received either of the Rejuvenate or ABG II Modular hips, or if you are unsure of the type of hip that was implanted, and you would like to talk with an attorney about how to determine whether you may have received one of the Stryker hips subject to the recall and lawsuits discussed in this article, contact Attorney Group to discuss your legal rights and available options.
Even if you are not currently experiencing any pain, swelling, or other symptoms that you believe to be cause by your Stryker artificial hip, you may still be able to recover compensation owed to you due to the implantation of either the Rejuvenate or ABG II Modular hips devices. Call Attorney Group today for a free consultation to learn more.