Stryker® Orthopaedics has been an innovator in the medical device market since the company’s founding in 1941. Today, Stryker® is an industry leader in the joint replacement market. Stryker® first obtained approval from the Food and Drug Administration for its Trident hip implant in 2003. The Stryker® Rejuvenate, another hip replacement product, was approved by the FDA in 2008 and the Stryker® ABG II was granted FDA approval in 2009.
The Trident, the Rejuvenate and the ABG II have now all been the subject of recalls because of problems and complications caused by these hip implant products. If you or a loved one experienced health issues and/or required a replacement surgery because of issues with a Stryker® hip replacement device, a lawsuit may make it possible to obtain compensation. A Stryker® hip recall lawyer at Michigan Injury Lawyers can help you take legal action, so call today to schedule your free consultation.
Recall of Stryker® Hip Devices
By 2005, just two years after its release, the Stryker® Trident had already begun to cause problems and the Food and Drug Administration began receiving adverse event reports. Complications that were reported to the FDA included walking difficulties, broken bones, breakage of hip replacement components, and significant ongoing pain.
Stryker® failed to respond to these complaints and failed to respond in a timely manner to FDA concerns about the manufacturing of some of its products. The FDA issued warning communications in March and November of 2007.
Stryker® did not act until January 2008, when certain components of the Trident system were subject to a voluntary recall. The two components removed from the market were the Hemispherical Cup System and the Acetabular Cup System. Both were manufactured at a facility in Ireland that the FDA had expressed concern about.
Despite the problems with the Trident, Stryker® released the Rejuvenate and the ABG II modular-neck system. Stryker® marketed the products heavily to younger patients by promising that these hip replacement components would offer added mobility, flexibility and longevity.
Complaints again flooded in, with patients indicating they had experienced a loosening of the implant, swelling, limited mobility, dislocation, and other problems including the replacement joint failing. A 2012 British Medical Journal study also pointed to problems with metal ions being released into the body due to the metal-on-metal design.
By 2012, Stryker® finally decided to take action after years of complaints. An Urgent Safety alert was issued in April 2012 warning of corrosion at the junction of the modular neck and the modular neck stem. In July of that year, both the Rejuvenate and ABG II systems were recalled.
What to Do If You Have a Recalled Stryker® Hip Joint
If you underwent a hip replacement or resurfacing and a Stryker® hip joint was used, take steps to ensure you have appropriate monitoring for signs of complications or hip implant failure. If your Stryker® product does fail, you should take legal action against the product manufacturer with the help of a Stryker® hip recall attorney.
Victims may recover compensation if they suffered injury as a direct result of Stryker®’s failure to release a safe product and/or because of Stryker®’s failure to warn patients of the risk. The fact that the products were recalled can provide support for an argument that the hip replacements were clearly defective. Under product liability laws, victims should be compensated for all financial and non-economic losses caused by defects or problems with the product when used as intended. Contact us today to speak with a member of our legal team to learn more about how we can help in your Stryker® lawsuit.