Intended to be used in total knee replacement surgeries, Stryker ShapeMatch Cutting Guides are single-use guides that assist orthopedic surgeons in accurately positioning the knee replacement components in patients. Stryker began selling the ShapeMatch in May of 2011. The device was designed to be used in conjunction with the Stryker Triathalon knee replacement system. ShapeMatch Cutting Guides direct the surgeon where to mark the bone before cutting to allow for a customized surgical approach. The ShapeMatch software uses 3D imaging data derived from a patient’s MRI or CT scans to develop these specifically tailored cutting parameters.
On April 10, 2013, the FDA announced a recall of these Stryker ShapeMatch Cutting Guides. Stryker, however, had instructed surgeons to stop using the ShapeMatch in November of 2012. A software defect causes the ShapeMatch system to render improper cutting ranges not intended by the surgeon. The result is that the depth and width of the surgical margins are too great, often leading to post-operative joint instability, fracture, chronic pain, limitation of mobility and the need for a revision surgery to correct these injuries. Stryker has recommended that all patients who received a Triathalon knee replacement in which a ShapeMatch Cutting Guide was used, to contact their surgeons if they are experiencing symptoms.
The ShapeMatch, like Stryker’s Rejuvenate and ABG II hip systems, is yet another example of a Stryker product being recalled after receiving 510(k) clearance through the FDA. Stryker anticipates a growing number of these claims, especially as patients’ knee symptoms deteriorate.
The attorneys at SUGARMAN are investigating ShapeMatch claims. If you or someone you know received a ShapeMatch guided Triathalon knee replacement, our attorneys would be happy to discuss the surgery and results with you. Please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.