Lawsuits from the defective hip recall of the Stryker Rejuvenate Modular and ABG II modular-neck hip stems continue to factor into the picture at Stryker. Second-quarter (Q2) results filed with the US Security and Exchange Commission (SEC) and released in July show the manufacturer continuing to deal with not only the ultimate total cost with respect to the Rejuvenate and ABG II situation, but a significant increase in product liability claims overall.
The company reported Q2 earnings that were down 3.1 percent for the period due in part, it said, to Rejuvenate and ABG II recalls.
In the years following the 2012 Rejuvenate recall, Stryker parent Howmedica reached a $1 billion settlement with roughly 3000 plaintiffs affected by the troubled and allegedly defective hip components. While the Rejuvenate hip system was not a metal-on-metal system per se, various components (since recalled) were fashioned from metal that reportedly contributed to a high failure rate and the introduction of metal ions to the bloodstream, together with the release of minute metal debris to surrounding tissue.
Historically, artificial hips were fashioned from ceramic and other heritage materials that consistently lent to a lifespan of 15 years under normal conditions. Faced with a greying (and growing) market – and a demographic that has been increasingly and consistently active throughout their adult life – medical device manufacturers pushed to develop updated products expected to withstand the rigors of a more active lifestyle, together with the hope to increase the average lifespan beyond 15 years.
The availability of the fast-track 510(k) Clearance through the FDA allowed for manufacturers to bring products like the Rejuvenate system to market faster, without the arduous clinical trials which delay the arrival of new products to market until they are thoroughly tested in real-world applications with study participants.
Provided an updated product is substantially similar to the original, it qualifies under the FDA 510(k) Clearance.
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Thus, the active patient seeking to continue their active lifestyle through hip replacement has often been left incapacitated yet again through the need for revision surgery to replace a failed implant.
The first payouts from the Stryker Rejuvenate Modular Hip and ABG II Modular hip stems $1B settlement began flowing in the summer of last year.
Meanwhile, the lawsuits keep coming. One of the most recent cases is Stallman et al v. Howmedica Osteonics d/b/a Stryker Orthopaedics et al, Case No. 0:16-cv-03322, filed September 30 2016 in US District Court, District of Minnesota and is part of multi-district litigation.