Knee replacement surgery has helped numerous individuals regain mobility and decrease pain. Approximately 700,000 knee replacement surgeries are performed each year in the United States, according to The New York Times. As the population ages, demand for knee implants has increased, leading many medical device makers to design and market new knee replacement systems.

OtisMed, a start-up company located in Alameda, Calif., seized on the opportunity and designed a system to help surgeons better tailor the knee replacement surgery to a patient’s unique anatomy. However, the company was able to bypass the U.S. Food and Drug Administration’s strict approval guidelines by claiming the “OtisKnee” technology was a low-risk system that did not require FDA approval.

OtisMed reportedly engaged in an aggressive marketing strategy and drew media coverage to let consumers know about the customizable OtisKnee. Surgeons were told that the OtisKnee would make surgery simpler and bring in extra money because it required MRI scans to ensure proper placement of the knee replacement implant.

Further, the OtisKnee would supposedly preserve more of the patient’s bone and ligaments, contributing to an improved fit and longevity. The OtisKnee marketing strategy worked, with demand for the knee implant product doubling month by month in 2007. However, there are concerns that the OtisKnee can be misaligned, resulting in joint instability, reduced mobility, pain and bone fractures.

According to the U.S. Justice Department, none of the promotional claims for the OtisKnee had been evaluated by the FDA. The FDA gives device manufacturers some flexibility when classifying their medical devices.

In the case of the OtisKnee, the manufacturer reportedly told the FDA it was a Class I (low risk) device that did not require clearance from the agency. However, when OtisMed sought clearance to market the OtisKnee in 2008, the FDA evaluated the product and determined that OtisKnee was a Class III device that required extensive testing. Further, the FDA found that OtisMed did not provide sufficient documentation to show the OtisKnee was safe.

OtisMed is not the only manufacturer that is currently taking heat for allegedly manufacturing defective knee implants. A growing number of reports are surfacing from patients who have allegedly received faulty knee replacements from Zimmer, Stryker, Smith & Nephew and DePuy. Consumers are taking legal action to hold these manufacturers accountable for designing, manufacturing and selling dangerous and defective knee replacement devices.

Failed knee replacement surgeries can be devastating to patients and their families. Some knee implant recipients have reported that they suffer severe pain and impaired mobility, requiring a second surgery to repair the failed knee implant. This second surgery requires even more rehabilitation time, lost wages, pain and suffering. In some cases, the damage from the failed knee implant renders a patient unable to work, putting a tremendous burden on the patients and their families.

If you were injured by an OtisKnee implant or another knee replacement product, fill out the form on this page now for a free legal review of your potential case.