Stryker Orthopedics is facing injury lawsuits from people who had a bad knee replacement because their bones were inaccurately cut by OtisKnee Cutting Guides, which were on the market illegally.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting OtisMed Cutting Guide induced injury cases in all 50 states. If you needed surgery for a Stryker knee replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What Are OtisKnee Cutting Guides?
OtisKnee Cutting Guides are single-use instruments that are used to correctly position bone cuts during knee replacement surgery with implants made by Stryker Orthopedics.
The surgeon must remove the ends of the leg bones and reshape the remaining bone to accommodate an artificial knee joint. The cuts must be extremely precise, because they are critical to the final result. Incorrect cuts can cause knee implant failure due to misalignment of components.
Symptoms of Knee Implant Failure
- Chronic pain
- Loose knee joint
- Limited mobility
- Knee fracture
- Failure of the implant
- Revision surgery
- Permanent disability
OtisKnee Lawsuit Filed Over Illegal Cutting Guides
In December 2016, a lawsuit (PDF) was filed by a woman from Pennsylvania who required revision surgery because her bones were inaccurately cut by an OtisKnee Cutting Guide. The 70 year-old woman had a total knee replacement in May 2008.
Her surgeon used OtisMed technology to make measurements, cut, and reshape her leg bones to fit her with an artificial knee. The implant failed to fix her knee problems. Instead, it loosened and caused severe pain and other complications that worsened progressively. Less than a year later, she required another surgery.
What is the problem?
In 2014, OtisMed Corporation and its former C.E.O. pled guilty to criminal charges and paid more than $80 million in fines for illegally selling OtisKnee Cutting Guides for knee implants after they were denied approval by the FDA.
Between May 2006 and November 2009, OtisMed distributed 18,000 unapproved OtisKnee Orthopedic Cutting Guides to surgeons throughout the United States, generating $27.1 million revenue, according to the New York Times.
In October 2008, OtisMed submitted an approval application. The FDA denied the application in September 2009 after determining that it was not “equivalent” to another device, or proven to be safe and effective. At the time, Stryker was preparing to acquire OtisMed for $100 million.
The FDA warned OtisMed not to sell the device. Even so, C.E.O. Charlie Chi ordered employees to ship a batch of 218 OtisKnee Cutting Guides between September 2 and September 9, 2009. In 2015, he was sentenced to 2 years in prison and paid a $75,000 fine.
Stryker Recalls ShapeMatch Cutting Guides
In April 2013, Stryker issued a recall for the OtisMed ShapeMatch Cutting Guides, which were used with the Triathlon Knee Replacement System after May 2011. The FDA received 44 reports of incidents related to the problem. Several lawsuits (PDF) have been filed against Stryker by people who were injured by ShapeMatch Cutting Guides and the Triathlon Knee Replacement.
Do I have an OtisKnee Lawsuit?
The Schmidt Firm, PLLC is currently accepting OtisMed Cutting Guide induced injury cases in all 50 states. If you had a bad knee replacement or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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