Though OtisMed Corporation did not receive Food and Drug Administration (FDA) clearance for its OtisKnee knee-replacement device, the company distributed and sold 18,000 of the devices from 2006 to 2009.
In December, OtisMed and its former chief executive pleaded guilty in Federal District Court in Newark to criminal charges of distributing adulterated medical devices. The company did not seek clearance from the FDA before it started selling the device and when OtisMed eventually did seek clearance, the application was rejected because the company failed to show that the product was safe and effective, the New York Times reports.About 700,000 knee replacements are performed every year, creating a huge market for implants and devices used in the surgeries. The OtisKnee was supposed to speed knee surgery through special cutting guides to help the surgeon precisely align the bone saw. The company used magnetic resonance imaging and three-dimensional software to create guides specific to the patient. The OtisKnee was supposed to preserve more of a patient’s bone and ligaments, and improve fit and longevity of the replacement knee.
Problems with the OtisKnee began showing up as early as November 2007, according to a ProPublica review of injuries and side effects reported to the FDA. Surgeons discovered that alignments were not right. One surgeon reported that in some cases he reverted to the standard knee replacement method redid the operation on the spot. OtisMed changed the materials used in the cutting guides, which might have led to warping when the guides were sterilized before surgery, the Times reports. A 2008 study in The Journal of Arthroplasty examined four cases and said, “The potential for malalignment with this system places implants at high risk of early failure.”
OtisMed reached an $80 million settlement of criminal and civil charges with the Justice Department. The former chief executive will be sentenced on criminal charges on March 18. He faces up to three years in prison and $300,000 in fines.