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FDA Rejected Cutting Guides Used in Knee Replacements

February 15, 2015  ·  By HM&M

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The OtisKnee device, made by OtisMed Corporation, was not approved by the Food and Drug Administration (FDA) to be used in knee replacement surgeries. The OtisKnee devices were not proven to be safe or effective. OtisMed Corporation distributed and marketed the OtisKnee and is responsible for product liability and the injuries patients have been caused due to the defective product.

“The OtisKnee device was used by surgeons performing total knee arthroplasty, known as knee replacement surgery. OtisMed advertised the cutting guide as a tool to assist surgeons in making accurate bone cuts specific to individual patients’ anatomy based on magnetic resonance imaging (MRI) performed prior to surgery,” according to the FDA’s statement about the OtisKnee, following a lengthy investigation.

The OtisKnee device was marketed to surgeons as a means to match the size and placement of the implant to an individual’s normal knee alignment. It was supposed to allow surgeons to be able to keep more of the patient’s bone and ligaments, which meant a quicker recovery and greater range of motion. Patients claimed their recovery was longer and many have had to undergo a second knee replacement surgery to remove the defective product, more bone, and have a new implant placed in their knee, costing them more recovery time and more medical expenses.

OtisMed Corporation was accused of distributing the OtisKnee device even though it had not been proven to be safe or effective, rejected by the FDA, and misled surgeons and hospitals in its marketing campaigns for the product. The FDA told OtisMed and former chief executive officer, Charlie Chi, not to distribute the product in the United States. Over 18,000 OtisKnee devices were still sold over three years.

Both OtisMed and Chi have pleaded guilty to criminal charges of distributing adulterated medical devices. OtisMed Corporation, which is a subsidiary of Stryker Corporation, has been fined $80 million in criminal and civil fines. Stryker Corporation recently awarded a billion dollar settlement to plaintiffs in a hip implant lawsuit. The OtisKnee defect is one of many lawsuits currently being disputed against Stryker Corporation.

OtisMed and Chi knowingly shipped defective products to surgeons for use after the FDA had told them to cease shipments. The attorneys at [[title]], P.C have experience representing clients in product liability cases, including defective Stryker hip implants. They have received verdicts and settlements totaling over $30 million.

OtisMed and Stryker Corporations have a responsibility to the patients affected by the OtisKnee defect. If you or a family member had a total knee replacement and your surgeon used the OtisKnee device, contact a Chicago product liability lawyer today.

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