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Stryker “ShapeMatch Cutting Guide” and its Complications During Knee Replacement Surgery Lead to Voluntary Manufacturer Recall

When implanted medical devices cause injuries to a patient, are improperly labeled or defectively manufactured, or otherwise fail after being implanted, a device manufacturer or the Federal Drug Administration will initiate a recall. Too often though, these recalls come after there have been hundreds of complaints filed by injured patients.

medical-doctor-1314902-m.jpgMost recently, Stryker, a leading medical device manufacturing company that specializes in developing orthopedic, neurotechnology and spine products, has issued a voluntary recall of one of its knee replacement products ShapeMatch Cutting Guides.

What Are ShapeMatch Cutting Guides?

ShapeMatch Cutting Guides are single-use, disposable cutting guides that are intended to be used as surgical instrumentation to assist surgeons in positioning the Stryker Triathlon Knee System. This software is used to guide where surgeons will cut and shape a patient’s bone before implanting the replacement knee device.

About the Recall

In April of 2013, Stryker Orthopedics issued a Level 1 voluntary recall of the Shape Match Cutting Guides, after becoming aware of the potential issues with the software. It was found that the software did not meet surgeon’s pre-operative planning parameters, and some manual edits used in the software did not meet the standards of the FDA. The overall effects these discrepancies in the software resulted in improper cutting of bones, as well as many serious adverse health consequences for patients who had Stryker system knee replacements including poorly-fitting, loose knee implants, knee fractures, chronic pain, and the need for revision surgery.

Your Consumer Rights

Like all knee replacement device manufacturers, Stryker has a legal obligation to properly design, test, and ensure their products are working correctly. They also are responsible for warning the public of any problems with their products, no matter how minor.

Often in these types of recall situations, manufacturers will issue a press release and establish a recall website to inform the public of their recall and offer support (help lines, compensation, etc.) to consumers who are affected by the device. While on the outside this appears to be a responsible thing to do, what many consumers do not realize, is that giving too much information upfront may limit their legal claims, should they decide to file a lawsuit. Providing a statement to the company may inadvertently limit coverage for injuries-since many clients may not know the true extent of their injuries. Companies may also pressure clients into providing their personal medical records and encourage doctors to share injury-related information in an effort to persuade clients to not file a claim. In addition, these companies may ask consumers to sign some sort of waiver, which in signing forfeits any rights to file a lawsuit.

If you find yourself in this type of position, and are questioning what your next step should be, it is in your best interest to consult with a legal expert who can help you understand your consumer rights and any documents related to your claim. At the law offices of Altman & Altman, LLP, our team of attorneys has five decades of experience handling all types of medical device recall cases, defective products cases, and product manufacturer liability claims.

If you or someone you know has received a Stryker knee replacement, or any other type of knee implant and have suffered adverse side effects following the surgery, do not hesitate to contact one of our lawyers. Our Massachusetts Products Liability lawyers have the knowledge and experience to help you through every aspect of your case-from consulting with your physician, to hiring a team of experts to determine liability for your injuries, and helping you receive the compensation you deserve for your injuries. Our lawyers are compassionate and understand the difficulties faced by clients who are the victim of a defective product, and we promise to guide you every step of the way until your case has settled. Call or email our attorneys today for a free initial consultation to discuss filing a claim. Our phones are answered around the clock, and attorneys are always available to answer any questions about your case.

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