Zimmer NexGen Knee Component Recall
In September, 2010 the FDA issued a Class II Recall related to the MIS Stemmed Tibial component – a part that may be used with both the Zimmer NexGen CR-Flex and LPS-Flex femoral components. Specifically, the surgical instructions informed orthopedics could implant the MIS Stemmed Tibial component without a drop-down stem – i,e., a peg that attaches to the bottom of the baseplate and is driven into the tibia for added stability. In the Spring of 2010, several prominent orthopedists issued a report at the AAOS describing concerns they had related to the use of Zimmer’s MIS Stemmed Tibial component.
In April, 2010, Zimmer issued an “Urgent Device Correction” to doctors alerting them that implanting the product without the stem was not recommended. Ultimately, in September of 2010, issued its recall that affected the MIS Stemmed Tibial component. The MIS Stemmed Tibial component was designed to be used with other NexGen femoral components including both the NexGen CR-Flex and LPS-Flex. The recall did does not address other tibial or femoral pieces.
Class 2 Recall
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
|Date Posted||September 13, 2010|
|Product||NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN.This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.|
Knee replacement is usually a success in the majority of people who have it. When problems do occur, most are treatable. Possible problems include:
- Infection – Areas in the wound or around the new joint may get infected. It may happen while you’re still in the hospital or after you go home. It may even occur years later. Minor infections in the wound are usually treated with drugs. Deep infections may need a second operation to treat the infection or replace the joint.
- Blood clots – If your blood moves too slowly, it may begin to form lumps of blood parts called clots. If pain and swelling develop in your legs after hip or knee surgery, blood clots may be the cause. The doctor may suggest drugs to make your blood thin or special stockings, exercises, or boots to help your blood move faster. If swelling, redness, or pain occurs in your leg after you leave the hospital, contact your doctor right away.
- Loosening – The new joint may loosen, causing pain. If the loosening is bad, you may need another operation. New ways to attach the joint to the bone should help.
- Dislocation – Sometimes after hip or other joint replacement, the ball of the prosthesis can come out of its socket. In most cases, the hip can be corrected without surgery. A brace may be worn for a while if a dislocation occurs.
- Wear – Some wear can be found in all joint replacements. Too much wear may help cause loosening. The doctor may need to operate again if the prosthesis comes loose. Sometimes, the plastic can wear thin, and the doctor may just replace the plastic and not the whole joint.
- Nerve and blood vessel injury – Nerves near the replaced joint may be damaged during surgery, but this does not happen often. Over time, the damage often improves and may disappear. Blood vessels may also be injured.
How We Can Help
Our team of attorneys is currently helping people throughout the United States who have been affected by the Zimmer NexGen knee component recall for the tibial plate component with filing claims. If you have received a knee implant and either have or will need to undergo revision surgery due to problems including loosening of the implant, chronic pain, or difficulty walking, you may be entitled to financial compensation.
There is a limited time to file a claim. Please contact us at your earliest convenience for a confidential, no-obligation consultation. It costs nothing to talk to us about your case. We are here to listen, offer our advice and help you determine what your legal options are. If you decide to pursue a claim, there are never any fees unless we recover compensation for you.
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