New Orleans, LAStryker ShapeMatch lawsuits have been filed against Howmedica Osteonics Corp (doing business as Stryker Orthopaedics), alleging patients were harmed by the use of the ShapeMatch Cutting Guide. The plaintiffs allege that issues with the ShapeMatch Cutting Guide, used with the Stryker Triathlon knee implant, resulted in knee implant failure.
ShapeMatch Cutting Guides are disposable cutting guides used to assist in positioning the knee during total knee replacement. Each guide is created individually based on the patient’s knee and is used to help the surgeon mark bone before cutting and positioning the knee components.
One lawsuit, filed by Melenena K. Smith, alleges Smith had total knee replacement surgery in June 2011, using a ShapeMatch Cutting Guide. The Stryker ShapeMatch Cutting Guide was the subject of a Class 1 recall in April 2013, due to issues with the cutting guide that could result in failure of the knee implant. Those issues included the cutting guide not meeting preoperative planning parameters and the displayed parameters not matching the cutting guide that is produced. Such issues can result in joint instability and fracture.
Patients who have had their knee implant fail have in some cases reportedly had to undergo knee revision surgery, in which the knee implant is replaced. According to The Louisiana Record (12/22/13), Smith’s lawsuit (number 2:13-cv-06740) alleges negligence, fraudulent concealment and violation of the Louisiana Products Liability Act.
In November 2012, Stryker e-mailed healthcare professionals and warned that they should stop using the ShapeMatch Cutting Guides until further notice. In January 2013, a Product Notification was sent to hospitals informing them about the issue. Then on April 10, 2013, an Urgent Medical Device Recall was issued. According to an FDA recall notification, the agency received 44 reports of incidents linked to the ShapeMatch Cutting Guides.
Although the ShapeMatch Cutting Guide is used with the Stryker Triathlon Knee System, the Triathlon Knee System is not part of the recall. The ShapeMatch Cutting Guides were approved by the FDA through a 501(k) clearance, given to products that are substantially similar to a device already on the market.
Patients who had a total knee replacement done with the use of the ShapeMatch Cutting Guide and are now experiencing problems with the knee, including joint instability, pain and limited mobility, may be eligible to file a lawsuit against Stryker.
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