New Orleans, LA (Press Release)In August 2013, Michael Hingle & Associates, LLC filed one of the nation’s first lawsuits against the manufacturers of the ShapeMatch Cutting Guide. The complaint alleges that the ShapeMatch Cutting Guide that was used to position a total knee replacement in Plaintiff’s body misaligned causing the knee replacement to be implanted in the wrong position.
The ShapeMatch Cutting Guides, manufactured by Stryker Orthopaedics, a Division of Stryker Corporation and Stryker Sales Corporation, are single-use, disposable cutting guides. They are intended to be used as surgical instrumentation to assist in the positioning of total knee replacement (arthroplasty) components intraoperatively and in guiding the marking of bone before cutting. The ShapeMatch Cutting guides are used with the Triathlon Knee System.
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The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via web application. When the parameters were manually edited to compensate for a defect in the existing software, the edits resulted in cutting guides ranges that are not cleared by the FDA. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g., depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.
On April 10, 2013, Stryker issued a Class I Urgent Medical Device Recall. Stryker is recommending patients who had knee replacement surgery in which ShapeMatch Cutting Guides were used and who are experiencing symptoms to contact their surgeon.
Michael Hingle & Associates, LLC, currently has one ShapeMatch case pending, in the Western District of Louisiana. The plaintiffs’ alleged injuries include pain, instability and the probable necessity for a second knee replacement surgery.
