Update on Stryker shapematch cutting guide developments
On behalf of Weisman, Kennedy & Berris Co., L.P.A. posted in Products Liability on Wednesday, March 5, 2014.
As Stryker hip implant lawsuits continue to proceed, litigation has also been filed against the medical device manufacturer regarding another of its products, namely, the Stryker ShapeMatch Cutting Guide (the Guide).
The Guide is a software-based tool that was designed to help surgeons performing knee-replacement operations. We first mentioned the Guide and some of the problems noted with it to our readers in a blog entry dated Feb. 4, 2014.
Reportedly, many persons who had knee replacements using the Guide are experiencing adverse ailments in the wake of their operations. Those have included reports of walking difficulties, structural misalignment, unusual sounds, compromised mobility and enduring pain.
As noted in a recent media article discussing the Guide, it received so-called “fast-track approval” (501 (k) clearance) from the United States Food and Drug Administration in May 2011. That enabled it to forgo the comprehensive and more exacting regulatory scrutiny typically required of medical devices seeking governmental approval. The Guide was essentially considered as an upgrade to already existing technology used for a well-established surgical procedure.
Things apparently went wrong quite quickly, with defective product concerns emerging. Stryker told surgeons to stop using the Guide in late 2012, and the company subsequently issued a recall last year in January.
The FDA then followed up that announcement three months later when, in April 2013, the agency classified Stryker’s call back as a Class I recall. The FDA website states that such a classification attaches when there is a reasonable likelihood that a product “will cause serious adverse consequences or death.”
We will keep our readers in Ohio and elsewhere duly apprised of any material developments that occur with the Guide or its related litigation.
Source: LawyersandSettlements, “Stryker ShapeMatch Cutting Guide system lasted just 18 months,” Gordon Gibb, Feb. 26, 2014
Tags: Products Liability