Did You Know... Zimmer Recalled NexGen Stemmed Tibial Component?
Brett EmisonFebruary 07, 2011 10:35 AM
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I reported at the end of January about orthopedic surgeons who urged a recall of the Zimmer NexGen CR-Flex artificial knee. But many are unaware that there has already been a recall of the Zimmer NexGen complete knee solution MIS total knee procedure stemmed tibial component.
Zimmer NexGen 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.
According to the Food and Drug Administration's (FDA's) recall notice, Zimmer has received complaints of loosening of the artificial knee implant device that required subsequent revision surgery in patients. As of September 13, 2010, Zimmer had received 114 Medical Device Reports (MDRs) all reporting that the NexGen artificial knee component loosened and the patient required additional surgery to replace the device.
Following the recall, Zimmer sent an "URGENT DEVICE CORRECTION" to orthopedic surgeons installing the defective knee component. Zimmer instructed surgeons to destroy or disregard all previous versions of the surgical technique and to review and familiarize themselves with the revised technique in light of the recall. Zimmer also warned surgeons to fully cement and pressurize the anterior and posterior surfaces of the tibial component and recommended the use of a drop down stem extension.
Loose knee implants can cause a variety of problems, including:
- Knee Replacement Failure
- Revision or Replacement of Artificial Knee Device
- Knee and Joint Pain
- Difficulty Standing or Walking
- Decreased Range of Motion
- Soreness or Stiffness
According to a report by the New York Times, Orthopedic surgeons -- Dr. Richard Berger and Dr. Craig Della Valle -- have urged Zimmer to recall the Zimmer NexGen CR-Flex knee replacement device. Dr. Berger was paid $8 million by Zimmer over a 10 year period to promote Zimmer artificial knee devices and train surgeons across the country on techniques to install Zimmer products.
However, by 2006, Dr. Berger found that 9 out of 108 patients needed revision surgery after only a year due to loosening of the implant due to partial fusing. According to Dr. Berger, the Zimmer CR-Flex failed in 8.3% of patients within about a year. The same study found approximately 36% of the replacement knees became loose within 2 years.
Dr. Berger says he reported the problem to Zimmer, but Zimmer rejected his concerns. Instead, Zimmer blamed Dr. Berger's technique for causing the problem (after previously praising Dr. Berger's "very clever set of hands").
Disturbingly, many artificial joints -- including artificial knees and hip replacements -- are cleared by the FDA without any testing in patients. In fact, Dr. Berger has claimed Zimmer did not have adequate data to evaluate the problem because Zimmer did not test the device in patients before selling it.
Just as troubling, there is no independent agency or "referee" to evaluate orthopedic implant safety because no one tracks the performance of orthopedic implant devices.
There have been a number of defective medical devices in news lately -- including the DePuy artificial hip recall and breast implants that may cause cancer.
How can these medical device companies let surgeons implant these devices without any patient testing? It is up to the public to ensure that justice prevails and defective medical devices don't hurt the very patients needing their help.
[More from the "Did You Know..." Series]
[More on Zimmer NexGen Artificial Knee Problems]
(c) Copyright 2011 Brett A. Emison