Product Defect - Encore Metal Hip Implants
Encore is another metal-on-metal hip implant that has been a cause of the serious ailment metallosis when the implant fails. This is a similar result in other recalled hip replacement devices that are made by DePuy ASR, the Zimmer Durom and the Smith & Nephew R3.
DJO Orthopedics of San Diego, CA, is the current owner of Encore. Compared to some of the larger hip replacement device companies, Encore is relatively small. However, there is no difference between Encore’s hip replacement product that causes the cobalt and chromium debris to accumulate in the hip joint area. That accumulation of debris leads to metallosis which is the process where metallic particles are circulated through the blood stream because of the metal-on-metal hip devices that allows for the breakdown of the metal to metal device.
The Encore hip usually comes with a metal-on-metal device which has a polyethylene liner in the cup that has metal that interfaces with the polyethylene that secures the metal ball on the femoral implant.
Metallosis can cause damage to surrounding tissue, swelling in the area of the implant, fluid buildup and the development of what looks to be visually a tumor. When these symptoms appear, orthopedic surgeons have regularly recommended that the hip be replaced and removed. This procedure is called a revision of the hip.
The Encore design which included the polyethylene and metal inlay was approved by the U.S. Food and Drug Administration (FDA) under a provision that prevents the preemption unity defenses that many manufacturers have raised when a new hip replacement device has been approved by the premarket approval process at the FDA.
The Encore hip device was first recalled by the FDA in 2001. At the time, the product was referred to as the Zirconia Ceramic Femoral Heads. Again in 2004, Encore Orthopedics initiated a recall due to labels being switched on two of their products. Those products were the Foundation Knee Systems and 3D Knee System.
In yet in another recall in 2008, Encore Orthopedics recalled its Foundation Knee System Tibial Fixed Impactor Component. That recall was initiated because doctors had reported that the Nitronic 60 screw on the tibial fixed impactor was breaking during surgery. Furthermore, Encore in the same year recalled its 3D Knee Tibial Insert Trial, a device used in surgery to determine the right size of the 3D Knee component to be implanted. According to the recall in 2008, the tibial insert trial was being incorrectly marked for its thickness.
It should be noted that the Encore metal-on-metal hip systems entered the marketplace by way of a less rigorous FDA process. That process has an order number 510k. It is known to be less rigorous than FDA order 522. Metal-on-metal hip systems are also noted to be Class III devices. Because there were less clinical data requirements under 510k, the problems with the metal-on- metal hip systems were more likely to create problems after they had been cleared for distribution and marketing. These Encore devices were “grandfathered”. The Class III devices include hip implants because they are designed to last for more than one year. Because of the problems associated with the Encore Orthopedics hip systems, the FDA has added that the failure of these hip systems would be reasonably likely to “cause pain, dislocation, or device loosening, leading to revision (any secondary surgical procedure), which would meet the definition of ‘serious adverse health consequences’.”
If you or someone you know has been injured as a result of a knee replacement device defect such as an Encore metal-on-metal hip replacement products, please call us for an immediate free consultation.
Robert Kreisman of Kreisman Law Offices has been handling medical device defect injury cases for more than 40 years. Kreisman Law Offices has prevailed in trials and settlements in Chicago, Illinois and surrounding communities and has successfully resolved cases for those injured because of knee and hip implant device defects.
With our 40 years of experience in trying and settling knee and hip implant device defect cases, Kreisman Law Offices provides the best possible services to our clients and have achieved unsurpassed results. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online. There is no charge for a consultation that will include an evaluation of your case, assessment of damages such as lost income, lost wages, medical and hospital bills, past and future pain and suffering, loss of normal life and wrongful death.