The Rejuvenate Modular Hip System was introduced as an alternative to the metal-on-metal hip joints that were becoming problematic due to metallosis: the introduction into the bloodstream of metal ions stemming from wear of the all-metal system. Hip replacement joints have been historically comprised of ceramic and other non-metal materials. The industry, in its wisdom, began switching to metal-on-metal joints in an attempt to make joints more robust - and perhaps last longer - a goal especially important for active seniors much less sedentary than previous generations.
What’s more, due to the 510(k) clearance allowed by the US Food and Drug Administration (FDA), a manufacturer undertaking an update to a device already on the market with a similar design is able to take a pass on the otherwise rigid testing and clinical trials normally undertaken for medical devices. This allows for design updates to reach the market faster. Unfortunately, it also removes the opportunity to properly vet the changes - including materials.
After having been brought to market, metal-on-metal devices were found to express small amounts of metal and metallic residue through wear, thus inflaming surrounding tissue and introducing metallosis, which is highly toxic. Stryker, in reacting to this problem, envisioned a hybrid joint that largely returned to more traditional materials such as ceramic.
However, a metal neck and stem was found to emit metallic debris under some conditions through wear, resulting in similar problems faced by full metal-on-metal devices. The situation resulted in the Stryker Orthopedics Rejuvenate Modular Hip System Recall in 2012 - three years ago this month.
As the result of many a Stryker recall lawsuit, Stryker negotiated a settlement agreement that was initially given praise for the speed at which the proposed settlement was reached. However, there would soon be criticism as to the tight timelines issued for would-be plaintiffs and beneficiaries to qualify for the settlement. The deadline was extended several times beyond its initial announcement in November 2014.
As of last month, it was announced that Stryker had achieved a 95 percent enrollment rate for eligible claimants to the settlement in accordance with the Master Settlement Agreement. As a result, Stryker Orthopaedics metallosis checks will begin to flow out to eligible Stryker recall lawsuit claimants this month. A report by Thomson Reuters ONE (6/12/15) indicates that the majority of payments will be made through the coming fall.
READ MORE STRYKER ORTHOPEDICS REJUVENATE LEGAL NEWS
Artificial hips have historically lasted upwards of 15 years under normal use. In the majority of cases, the Stryker Rejuvenate hips were failing well before that - many within five years and some within just 18 months. Little wonder so many plaintiffs hit Howmedica Osteonics Corp. - doing business as Stryker Orthopaedics and serving as a subsidiary of Stryker Corporation - with a hip replacement lawsuit.