The FDA approved the Zimmer NexGen knee for sale in 1994. Since then, millions of Zimmer NexGen knees have been used in knee replacement surgeries. Now, certain Zimmer NexGen knees have been associated with unexplained pain and stiffness after surgery, difficulty walking, loosening of the implant, and the need for revision surgery.
According to the American Academy of Orthopedic Surgeons, the CR-Flex Porous femoral component is a main concern.
Dr. Della Valle and Dr. Berger, both of Rush University Medical Center revised 8.3% of the 108 patients’ knees that were under evaluation due to femoral loosening and pain. The study reported that 36% of the patients showed evidence of radiographic loosening. Ruling out the approach, patient type and surgeons, they concluded that a design defect was the cause for the early failures.
Unlike components that use bone cement to secure them into place, porous components like the CR-Flex rely on tiny holes in the device for healthy bone to grow into and secure. This is called “osteointegration.” As the study points out, “Most reports of cement-less femoral components in [total knee arthroplasty] have demonstrated excellent osteointegration and low revision rates; in fact, a very high rate of osteointegration of modern cement-less femoral components is taken for granted.”
However, as the study suggests, not all cementless components are equally effective.
Dr. Richard Berger has requested a cement-less Zimmer NexGen CR-Flex Knee Replacement recall by the FDA. Although Zimmer has issued no recall, injured patients are already filing claims seeking compensation for their injuries.
GoldenbergLaw, PLLC believes that companies should be held accountable if their devices are not performing up to standards. If you believe you or a loved one has received a defective knee implant, please contact us by filling out our online contact form, or call our office for a complementary consultation.
GoldenbergLaw is currently handling defective Zimmer NexGen knee cases in Minnesota and throughout the nation and has been litigating mass tort drugs and devices for over 30 years. We are working with other experienced firms to make sure our clients get the compensation they deserve.
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