Recently, The New York Times shared a case report of a woman who allegedly suffered serious injury due to the OtisMed cutting guide, a tool used in her knee replacement surgery.

The OtisMed cutting guide is a surgical tool used in knee surgery. The device is designed to help surgeons during knee replacement surgery by helping them measure and cut to better accommodate a patient’s unique knee joint during knee surgery. The OtisMed cutting guide is marketed as a way of making knee surgery simpler, easier, and better. However, at least 58 reports of serious knee problems have surfaced in patients who had knee surgery with the OtisMed cutting guide.

In the case report described by The New York Times, a real estate agent from Oregon named Carla M. had knee surgery. During her knee surgery, surgeons used the OtisMed cutting guide. When Carla awoke, according to The New York Times article, she experienced severe knee pain. The pain was so debilitating that Carla was reportedly unable to work and was actually forced to file for bankruptcy in 2009. She reportedly required surgical correction to stop her severe knee pain after her first knee surgery.

Despite dozens of reports of knee pain involving the OtisMed cutting guide, this knee surgery tool is a major money-maker for its manufacturers. In fact, between May of 2006 and September of 2009, the OtisMed cutting guide reported more then $27 million in sales with more than 18,000 units sold to knee surgeons.

OtisMed Criminal Issues

The OtisMed cutting device may have something of a checkered history. The knee surgery device’s manufacturers originally marketed the device as a Class I device, the lowest category of risk in the FDA’s system of classifying medical devices. However, the FDA asserted this knee surgery tool was actually Class III or high risk. This forced the knee surgery guides to apply for additional FDA approval in 2009. This approval was ultimately denied, but the company shipped over 200 units to surgeons after the denial. The CEO responsible pleaded guilty to criminal charges, and is now facing both a $300,000 fine and jail time. At the same time, the company reached an $80 million settlement with the Department of Justice in 2014 over these and other related allegations.

A class action knee surgery investigation has been launched to explore the possibility of a class action knee surgery lawsuit, based on allegations that the makers of the OtisMed cutting guide knowingly sold a defective knee surgery tool for years, causing serious pain and other knee replacement complications. Such knee surgery lawsuits could seek to recoup the costs of medical care and other costs related to knee surgery with this knee surgery tool.