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On April 10, 2013, Stryker Orthopaedics issued an Urgent Medical Device Recall relating to some of its knee replacement systems. Based upon dozens of complaints from patients experiencing joint instability, fracture, need for revision surgery, chronic pain, and range of motion limitations, Stryker has determined that its ShapeMatch Cutting Guides, upon which surgeons rely on positioning the knee replacement and marking the bone before cutting, was defective. The ShapeMatch Cutting Guides were first taken off the market in November 2012.
The Food and Drug Administration has categorized the recall as a Class I recall, the most serious type of recall, involving “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” According to Stryker, the ShapeMatch Cutting Guides “are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the making of the bone before cutting.”
According to the FDA, it has . . . notified healthcare professionals of a Class I recall due to a software defect that results in wider cutting ranges. The parameters of the manufacturers cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. 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 joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.
In a press release, Stryker has indicated these issues were identified through standard post-market surveillance of product complaints. Stryker is recommending that patients who are experiencing problems following a knee replacement surgery involving the ShapeMatch Cutting Guides consult their surgeon.
Potential problems following total knee replacement surgery involving Stryker ShapeMatch Cutting Guides include pain, misalignment, loose or unstable knee prosthesis, fractures, reduced range of motion, stiffness, limping or the need for further surgeries. Some or all of these problems may be permanent.
Under product liability law, Stryker may be held liable for damages proximately caused by a defect in its product. This means that if Stryker has marketed a defective product and the defect plays a substantial part in causing damages to a consumer (in this case, a patient), Stryker may be held liable to compensate the consumer for the causally-related damages. Compensable damages include pain and suffering, loss of function and/or disfigurement, lost wages and impairment of earning capacity, loss of enjoyment of life and medical bills.
The attorneys at Colucci, Colucci & Marcus, P.C. have a long history of successful prosecution of all types of personal injury claims, including product liability. Experienced and aggressive attorneys are essential to the successful prosecution of these types of claims. Attorney Kevin Donius and the medical device/ product liability team at Colucci, Colucci & Marcus, P.C. are currently evaluating claims throughout New England against Stryker based upon the recall of the ShapeMatch Cutting Guides.
For a free consultation and evaluation of your potential claims, please call 617-917-3917.
