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
Recall Number Z-2410-2010
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.

 

From 2008 through 2009, Drs. Richard A. Berger and Craig Della Valle of Rush University in Chicago, Illinois reviewed 108 patients where a Zimmer NexGen CR-Flex femoral component was surgically implanted.  At the American Academy of Orthopedic Surgeons (“AAOS”) in 2010, Dr. Berger reported that nine of his patients had to undergo revision surgery within two years of the original implant surgery due to early aseptic loosening.  Revision surgery typically is performed when the femoral or tibial component have loosened to the point that they need to be replaced. Another 36 percent of the recipients also reported pain and loosening, which was confirmed with additional testing procedures.

The Food and Drug Administration (“FDA”) issued a Class II recall in September 2010 involving certain surgical techniques related to a specific tibial component Zimmer, Inc. designed and manufactured for use in relation to a NexGen High-Flex knee replacement. This recall is only for a specific knee component associated with Zimmer’s knee products. Some knee surgery patients have reported having problems involving the Zimmer knee. It is estimated that since 2003, the NexGen CR-Flex and LPS-Flex knee replacement has been implanted in more than 150,000 patients. Additionally, Zimmer sold approximately 68,000 units of the tibial plate affected by the FDA recall worldwide. A number of patients have already reported having knee replacement complications and problems including: serious or ongoing pain, infection, swelling and loosening or dislocation of the knee implant or components.

Finally, in December of 2010, the FDA announced a second recall involving certain component parts associated with several Zimmer knee replacement parts including the NexGen LPS-Flex. The recall involved manufacturing problems associated with the NexGen LPS-Flex that could result in premature failure.

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 received a knee implant and either have or will need to undergo revision surgery due to problems including loosening of the implant or knee failure, 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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