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.
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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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Phyllis Ann Good
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Case 3:14-cv-00430-DRH-PMF filed in 7th District Federal Court - Southern District of Illinois - east Saint Louis Division
Posted on April 16, 2014
On Friday April 11, the law firm of Zoll, Kranz & Borgess, LLC filed a lawsuit behalf of a group of fourteen plaintiffs against Howmedica Osteonics Corp. (which does business as Stryker Spine) alleging Howmedica’s trial device called called CerviCore injured them.
According to the Complaint filed in Federal Court, nine of the plaintiffs had the device installed as part of an experimental trial conducted by Stryker. Four additional plaintiffs are spouses of the original nine and have suffered as a result of their husband’s or wife’s suffering.
The CerviCore device is an experimental metal-on-metal device that was implanted in between two cervical spine vertebrae. Stryker bills the device as an alternative to traditional fusion surgery.
Study documents show that up to 400 people may have been part of the study, with around 200 of them receiving the CerviCore device. It’s not known how many of those are suffering because of it.
All nine plaintiffs in this suit say the CerviCore device has caused them grave harm. Most or all are suffering metallosis symptoms and they allege Stryker either will not conduct proper metal exposure testing or conducted testing and will not release the results. The symptoms are very similar to the metallosis alleged to be caused by Stryker replacement hips.
Additionally, all nine say Stryker / Howmedica abandoned them. In most cases, the company sent a representative saying Stryker wanted to continue the CerviCore study, then, shortly after they signed new waivers, it abruptly ended the entire study and stopped monitoring their conditions.
The suit seeks damages for all the medical expenses, the lost work time, and the pain and suffering each person has endured. It also asks the court to punish Stryker / Howmedica and send a message that the way it treated these people is unacceptable.
Stryker / Howmedica has yet to respond to the allegations.