Knee joints suffer a high level of wear and tear, often causing great aches and pains. A variety of manufacturers offer many different implant devices. Educating yourself about what is available can help you ask your doctor the right questions.
How to Determine if you have a Recalled Knee Implant
Some of the larger recalls over the past five years are listed below. To determine if your knee implant has been recalled, contact your orthopedic surgeon directly. If you don’t know who performed your knee implant surgery, consult your primary care physician or the hospital where the surgery was performed.
RECALL: Persona Trabecular Metal Tibial Baseplate (cement-less) Zimmer’s Persona Knee was hailed as an “implant system that addresses the unique needs of the patient and accommodates surgeon specific preferences.” However, in February of 2015, Zimmer, Inc. voluntarily recalled its cement-less Persona Trabecular Metal Tibial Baseplate devices that were implanted between 11/29/12 and 1/23/15. (Only tibial sizes C – J.) The device failed to adhere to the tibial bone, which results in loosening and ultimate failure of the device. This, in turn, leads to revision surgery to replace the defective product. Surgery after a failed knee replacement is a much more painful surgery and exposes the patient to longer periods of rehabilitation, infections, and other post-surgical complications.
WHAT DOES CEMENT-LESS MEAN? Zimmer, in an attempt to reduce the patient’s exposure to the foreign components of cement, instructed physicians to implant the device by impacting it onto the femoral component without cement. However, the device has been found to have an inadequate porous coating design that does not adhere to the bone.
|September 2010||NexGen® MIS Total Knee Procedure Stemmed Tibial Components. Zimmer NexGen LPS-Flex||MIS procedures are inherently challenging and can involve reduced visibility, which may lead to difficulty with achieving proper implant alignment & cement fixation.|
|December 2010||NexGen® Complete Knee Solution Legacy® Posterior StabilizedFlex (LPS-Flex) Femoral Components (LPS-Flex)||Tendency to loosen and FDA reports “collapse” of the component that requires revision surgery.|
|January 2012||NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Female CR-Flex (GSF CR-Flex)||Loosening, pain in the joint, premature failure of device.|
|January 2012||NexGen® Complete Knee Solution Gender Solutions™ Female LPSFlex (GSF LPS-Flex)||Inner package may interfere with outer seal resulting in lack of assurance of sterility.|
|Unknown||NexGen® Complete Knee Solution Cruciate Retaining-Flex Femoral Components (CR-Flex)||Loosening, pain in the joint, premature failure of device|