Zimmer NexGen High Flex Knee Implant
Zimmer NexGen High Flex Knee Implants with MIS Tibial Baseplates
Under Legal Scrutiny
A number of lawsuits have been filed alleging that the Zimmer NexGen High Flex Knee Implants combined with MIS tibial baseplates are defective products. A 2010 Study by Berger entitled: The High Failure Rate of a High Flex Total Knee Arthroscopy Design concluded that the implants that were the subject of that study “should not be used in any patient.”
It should be noted that most of the Zimmer Nexgen Knee implants sold worldwide are a different type that that the combination that was the subject of the 2010 study. The knee implant registries around the world do not show a higher than normal failure rate for NexGen knees. Further, there does not appear to be any further literature since the Berger Study.
Nevertheless, the lawsuits against Zimmer allege that the NexGen High Flex Knee combined with the MIS tibial baseplate results in failures caused by the high flex of the knee causing the MIS baseplate to pull free from the tibia. The MIS designation refers to Minimally Invasive Solutions.
The MIS tibial component has a shorter stem from the plate on top of the tibia into the tibia. This lack of a deeper anchor in the tibia could be the cause of failures of this implant combination. The advantage of the MIS tiabial baseplate according to Zimmer marketing is that it is less invasive to implant and that surgical outcomes may be improved as a result.
In April of 2010 Zimmer began recommending a drop down stem extension for this MIS tibial baseplate. This would appear to provide more stability to the tibial baseplate because it would anchor the plate more deeply into the tibia. Further, in September 2010 the instructions were changed for the surgical technique to recommend that the surgeons fully cement and pressurize the anterior and posterior surfaces of the tibial component. It is my personal opinion that these changes were likely to be a response to reports of failures of the NexGen High Flex Knee with the MIS tibial baseplate.
Zimmer has faced a number of other lawsuits since 2008 over its Zimmer Durom Cup Hip Implant which is no longer sold. The Zimmer Durom Cup multidistrict litigation is proceeding in the U. S. District Court in Newark New Jersey. There are also Zimmer Durom Cup lawsuits pending in State
Courts. I do not believe that there is a multidistrict litigation that has been
created for the NexGen High Flex Knee lawsuits.
In 2011 Zimmer has filed its own lawsuit against some law firms for defamation and trade mark infringement for running advertisements stating that the NexGen Knees had been recalled or that they had a high failure rate.
These advertisements were seeking clients who had failed NexGen Knee Systems. The lawsuit by Zimmer alleges that this advertising is untrue and that it has hurt Zimmer’s reputation and its sales.
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