What Performance Claims Did Stryker Make?
Hip manufacturing from a variety of companies has previously had issues regarding friction and corrosion of metal materials in the body. To avoid this dangerous corrosion, Stryker claimed their Rejuvenate hip device was resistant to the degeneration and corrosion of the metals. This claim led medical professionals to believe the product to be safe and long-lasting for their patients in need of a hip implant.
Styker also claimed the hip stem would:
- Offer Flexibility—As many surgical hip patients have trouble with movement, Stryker had promised intra-operative flexibility of the implant’s modular design. The company also touted the ergonomic enhancements included in the modular neck design. These enhancements were stated to be instrumental to the device manufacturing in promises of avoiding corrosion.
- Enhance Stability—Stryker claimed the Rejuvenate product would enhance stability by matching the mechanics of the device instrument to the individual’s anatomy. The company stated the biomechanic structure would lessen the risk of dislocation, a common concern for many hip implant patients.
- Include Modular Components—The modular neck components present in the Rejuvenate device are said to include 8-10 different parts meant to match each patient, based on the hip surgeon’s discretion. Stryker publicly stated, “Every patient’s anatomy and lifestyle are different, which is why we have invested in developing cost-effective personalized hip solutions”.
Why Did Stryker Choose Metal for the Rejuvenate Hip Implant?
Stryker chose a combination of metals in the construction of the Rejuvenate hip implant including cobalt, chromium, and titanium. These metals were chosen with the notion of avoiding corrosion in a patient’s daily life with an alloy brand called Vitalium. Vitalium was chosen with the attention of having a hard metal that would uneasily loosen near the hip joint.
Why Was the Rejuvenate Hip Replacement Design Faulty?
Patients across the globe have been injured or left ill due to joint destabilization and metal corrosion of the Rejuvenate device. The metal corrosion led to metal poisoning or metal toxicity in thousands of hip implant orthopedic patients. Due to the 510(k) Premarket Notification Process, Stryker was able to avoid clinical testing and move forward with marketing the hip implant device. The 510(k) process allows companies to skip past clinical trials and avoid the massive research expenses that come along with it. Despite FDA approval, the ABG II and Rejuvenate devices designed by stryker were never tested on a human before being opened to purchasing capability by healthcare companies.
What Problems Arose from the 510(k) Process?
Since companies like Stryker can skip testing with a 510(k) process, by the time complaints regarding the effects of the device are filed, the company has already made a profit through clinical sales. This process leads doctors to adhere to surveillance of the device in patients to see if there are any reports of issues. Unfortunately, the patients undergoing hip replacement surgery are held responsible for taking note of their health status post-operation and communicating with doctors thereafter. This faulty design and lack of clinical testing have caused many patients to sue for the lasting impact the device can have on an individual’s health and mobility.
What Are the Side Effects of the Stryker Rejuvenate?
Tissue reactions have occurred in thousands of patients who have used the Stryker Rejuvenate. These adverse reactions have determined the Rejuvenate implants to have a failed design.
Side effects reported by patients include:
- Necrosis—Necrosis is the tissue death and dissolution of bone joints from metal toxicity.
- Metallosis—Metallosis, or metal poisoning, is caused by the corrosion of metal pieces that are released into the bloodstream during active friction of the device. This friction causes poisoning in surrounding tissue debris.
- Surgery Reconstruction—Since the device can lead to bone fractures, many patients need to go through reconstructive surgery to repair the subsequent bone fractures.
- Surgery Revision—Failure of the Rejuvenate device has caused necessary revision surgeries in patients to remove the failed device and later replace it with a different device.
- Inflammation—The hip implant device may cause inflammation throughout the entire body due to its failure. This inflammation sometimes includes pain and fatigue.
- Destabilization of Joints—Difficulty moving has been a common occurrence for patients with the Rejuvenate device. As the joint corrodes, the joints lose stability. This stability makes it difficult for patients to walk or continue an active lifestyle.
The side effects reported from the Stryker hip device have led patients to undergo more invasive treatments or surgical procedures. The longer recovery period from metal-on-metal poisoning continues to be one of the root causes of Stryker lawsuit cases.
Is There a Rejuvenate Hip Implant Recall?
The Rejuvenate hip implant device was recalled in April 2012 by the FDA. This was a Class 2 recall for its ineffective modular-neck stem. Before and after the recall period, Stryker sent out an apologetic safety notice for practitioners detailing the ion hazard from the excess metal debris. They continued their notice with statements regarding the inflammation in the surrounding tissues and joints of the hip socket that can be caused by metal-on-metal friction. This recall by the FDA caused production of the devices to pause and the completion of sales for Stryker Orthopaedics.
What Rejuvenate Lawsuits Are There?
The modular-neck hip designs manufactured by Stryker have over 4,000 lawsuit claims against them. These lawsuits have been rooted under the false claims of Stryker Corporation and their failure to accurately warn both medical professionals and public users of the effects of the Rejuvenate device. The lawsuits are presently in both federal and state courts in multi-district litigations (MDLs). Lawsuits present in the New Jersey Supreme Court have been consolidated as a part of a class action lawsuit, and as of 2022, there remain 105 more cases against Stryker and its affiliates.
What Rejuvenate Lawsuit Settlements Have There Been?
The Rejuvenate settlement claims have been listed at 1 billion dollars. While the company had an initial payout of over 1 billion dollars, there is no liability cap for Stryker. Only some cases of Rejuvenate failure have been settled in the courses, and more cases are expected as patients continue to have adverse effects. It is estimated by legal and regulatory officials that the payout Stryker will owe is likely to far exceed the initial settlement of 1 billion dollars as patients with injuries or metal-on-metal toxicity continue to come forward in court and seek compensation for their chronic suffering on behalf of the Stryker Orthopaedics company.
Who Qualifies for a Rejuvenate Hip Implant Lawsuit?
A patient may qualify for legal compensation if they have had financial distress or ongoing cases of metallosis due to the Rejuvenate hip replacement device.
Qualifiers of a legal settlement with Stryker may experience issues including:
- Dislocation of the joint
- Metallosis (metal poisoning)
- Pain and/or inflammation
- Income loss
- Mobility problems
- The revision or reconstructive hip surgery
- Unforeseen medical expenses
- Bone fracture
If you or someone you know has had hip implant surgery with the Rejuvenate modular-neck device or have needed corrective surgery you may be eligible to receive legal payment from a settlement against Stryker for the failure of the device. Confirmation of eligibility is possible after speaking with a certified attorney.
How Do I Find a Hip Implant Attorney?
For a consultation regarding your Stryker Rejuvenate case, contact Seeger Weiss for a free evaluation. Until a settlement in court against Stryker Orthopaedics is confirmed and successful, your consultation with Seeger Weiss remains free of charge.