OtisKnee Knee Replacement | Product Liability Attorney
Did you or someone you love undergo a knee replacement surgery that utilized OtisMed Corporation’s OtisKnee guides? Portland injury lawyers at Paulson Coletti answer some common questions about these devices.
Who manufactured OtisKnee devices?
OtisKnee knee replacement guides were manufactured by OtisMed Corporation or “OtisMed.”
Are OtisKnee devices still being used in knee replacement surgeries?
In September 2009, the U.S. Food and Drug Administration told OtisMed that it’s submission to get pre-market approval was denied because OtisMed failed to demonstrate that their product was as safe and effective as other, similar devices. According to the FDA, a week after OtisMed received this denial notice, they continued with their shipment of more devices to surgeons throughout the nation.
When were these devices used?
OtisMed marketed and sold their OtisKnee guides from May 2006 until September 2009.
Where were these devices used?
OtisKnee devices were sold and distributed to physicians throughout the United States.
How were the OtisKnee guides supposed to work?
OtisKnee guides were manufactured to assist surgeons during knee replacement surgeries. The guides were supposed to, claimed OtisMed, guide incisions with greater precision, resulting in minimal bone/ligament loss which could improve the way the replacements fit and how long they could last.
How many people were injured by OtisKnee?
By the end of 2009, the FDA had received 58 reports of injury from consumers who underwent knee replacement surgery using the OtisKnee. There is no concrete figure for how many patients may have been harmed by the guide.
What types of injuries were reported?
According to the Justice Department and the FDA, most of the complaints were the same or very similar in nature, usually involving claims that the guide did not fit properly and was difficult to secure. Some patients report having to undergo revision surgery due to pain and immobility.
Is there money available for victims?
OtisMed agreed to set aside more than $40 million to resolve its civil liability in relation to OtisKnee malfunctions. If you have legal questions or concerns involving a knee replacement surgery, specifically one that used OtisKnee, we invite you to contact us for an evaluation of your case as these issues are extremely complex.
Paulson Coletti is available to take your calls at (503) 226-6361 or you can fill out and submit a free case review form.