Did you or someone you love undergo a knee replacement surgery that utilized
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
Are OtisKnee devices still being used in knee replacement surgeries?
In September 2009, the U.S. Food and Drug Administration told OtisMed that
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
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
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) 433-3524 or you
can fill out and submit a
free case review form.