Stryker, which is one of the leading manufacturers of hip replacement implants, introduced their Rejuvenate model in 2008 after FDA approval under the 510(k) program.
The FDA’s 510(k) program allows companies to offer medical devices or drugs to the public without clinical trials in instances where the product is remarkably similar to another product that is currently on the market. If the other products have already received FDA approval, manufacturers can release newer technologies on the basis that they will conduct post-market surveillance to determine the safety and efficacy of the product. While this option for approval tends to work without major issues, in the case of the Stryker Rejuvenate hip implant, it led to potential problems going unnoticed until after patients began experiencing problems with the devices. Unfortunately, the technology on which these implants were based also began showing problems leading to recalls, with essentially the same problems as the Stryker components is having now.
The major difference between the previous technology and the Stryker were somewhat slight. The previous options were a ball on ball metal components for the socket, while the Stryker was a metal two-hip modular-neck system. While the former was considered metal on metal, the latter was not since it did not utilize the metal ball and metal socket construction. However, the neck-hip junctions in the device do result in the same metal rubbing against the metal issue.
Urgent Safety Alert
After studies had been released on patients with the Rejuvenate hip implant, Stryker issued a statement in 2012 known as an Urgent Safety Alert. In this alert, the hazards listed included:
- The potential for excessive amounts of metal debris
- Metal ion generation
Both of these hazards were due to fretting, which is essentially corrosion or metal shavings that occur due to the metal components rubbing together, causing the metal flakes and ions to be released into the blood stream and tissues. When this occurs, it can result in:
- Metallosis – Metal poisoning that occurs due to toxicity caused by the release of metal ions
- Necrosis – The premature death of tissue
- Osteolysis – Dissolution of bone
- Formation of pseudotumors
- Pain and swelling
These adverse reactions required revision surgery for correction, as well as additional treatments needed to address infections and other conditions resulting from the tissue and bone damage.
In 2012, Stryker issued a voluntary recall of the Rejuvenate device after over 60 reports were filed with the FDA concerning adverse events. In addition to the recall, the company also advised patients to undergo evaluations using blood tests, MRIs, and X-rays to determine whether dangerous levels of metal ions were present. According to medical professionals familiar with these cases, if adverse reactions in the tissues or bones occur, revision surgeries, as well as other operations, may be required to intervene and prevent further pain and damage.
Unfortunately, the nature of the Stryker Rejuvenate hip replacement is somewhat problematic when it comes to revision surgery. These implants use a stem that is inserted far into the femur. As a result, there is an increased risk of fracture occurring during the revision process, leading to additional pain and potential complications for the patient – with some requiring reconstruction of the femur due to the bone-weakening from the metal ion exposure.
If you were given a Stryker Rejuvenate hip implant and required revision surgery or suffered from metallosis, tissue or bone damage or other complications resulting from the release of metal ions or shavings, you are strongly urged to contact an attorney. You may be eligible for compensation in your case due to the company’s recent settlements issued to patients receiving these implants.