Medical Technology Company, Stryker Corporation, Recall
Their LFIT Anatomic CoCrV40 Femoral Head has been recalled due to a significant rate of failures and complications with its use in patients who receive the device during hip replacement surgery.
The recall is considered to be a Class II hip device recall according to the Food and Drug Administration (FDA). The FDA defines a Class II device recall in their Investigations Operations Manual as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
What Was Recalled?
The femoral head is a ball shape which is attached to a femoral stem via a small metal rod. The femoral head is placed at the top of the femur bone in the socket of the hip near the pelvic bone, while the femoral stem is inserted into the femur. Although it is expected to be reliable, over time the metal rod that joins the femoral head and stem together is prone to significant corrosion. This corrosion leads to taper lock failure which allows for loosening and dislocation of the device.
Health Dangers and Risks
Without the metal rod in place, the femoral head and stem start to scrape on each other and metal particles are released into the bloodstream inducing blood poisoning. Mobility issues, tissue inflammation, pain and discomfort are also serious issues that can arise.
Call our office at 303-999-9999 or 303-835-9342 if you or a loved one have received one of these devices during hip replacement surgery or are experiencing complications. We can also be reached via our website.