Zimmer NexGenKnee Replacement Recall
- Knee Information
- Knee Replacements
- NexGen CR-Flex Knee
- NexGen LPS Flex Knee
- NexGen Knee Recall
- NexGen Knee Lawsuit
- MIS Tibial Component
- Hip Information
- Hip Replacements
- Zimmer Durom Cup
- Hip Lawsuit
Recent concerns about the higher-than-normal failure rate of NexGen CR-Flex Knee replacements have prompted many to question the use of the knee device and others to push for a recall of the CR-Flex Knee.
In July 2010, Senator Charles E. Grassley, of Iowa, requested that Zimmer Inc., the manufacturer of the knee devices, disclose its method of tracking the performance of orthopaedic devices after an outside consultant raised concerns about the premature failure of the CR-Flex knee device. Grassley also asked for a list of the safety concerns raised by the Zimmer Inc. consultant, Dr. Richard Berger.
Berger questioned the device failures found in patients who received the CR-Flex Knee after he worked to design tools and artificial joints for Zimmer Inc. Dr. Berger has since issued a statement recommending that the knee devices should not be used in any patients.
According to study results presented at a conference of the American Academy of Orthopaedic Surgeons, femoral components in the CR-Flex Knee implants were found to loosen in 36 percent of patients. About 9.3 percent of patients with the CR-Flex Knee device were required to undergo a revision surgery two years after the initial surgery. The knee implant has also been found to last for only three years, while normal knee replacements typically last for 15 years.
FDA Forces Recall Of Zimmer NexGen Replacement Knee
The U.S. Food and Drug Administration (FDA) on two separate occasions targeted Zimmer Holdings in major product recalls – its NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays and MIS Modular Tibial Plates and Keels.
In September 2010, the FDA ordered a Class II recall for Zimmer’s NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays, and MIS Modular Tibial Plates and Keels. These component parts were recalled due to a “noncomforming geometry” that kept their locking screws and stem extensions from properly interlocking with each other. Their tendency to dislocate resulted in complications such as pain, infection, immobility, and osteoarthritis.
According to the FDA recall notice, the manufacturer had received 114 Medical Device Reports (MDRs) of patients who had problems with this device, or who needed revision surgery to replace the implant because it had become loose.
The recall covered 68,384 products in worldwide distribution and included the following countries: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Taiwan and Thailand; and 13 U.S. states: Arizona, Illinois, Indiana, Kentucky, Missouri, Nebraska, New Mexico, New York, Ohio, Texas, Virginia, Washington and Wisconsin.
Because the NexGen MIS Tibial Component can be used with either the CR-Flex or the LPS-Flex replacement systems, it is reasonable to assume that many defective parts had already been inserted in an unknown number of patients. However, the recall did not address other components of the NexGen CR-Flex or LPS-Flex replacement systems, nor the complete systems, themselves.
Instead Zimmer revised the implant’s “Surgical Technique and Instructions for Use” to warn doctors that they should “fully cement and pressurize the anterior and posterior surfaces of the tibial component and to strongly recommend the use of a drop down stem extension,” i.e., a peg that attaches to the bottom of the tibial baseplate and is driven into the tibia for added stability. Heretofore the use of the stem was listed as optional.
Although the company did send letters to surgeons and hospitals asking for the specified components to be returned, no press release appears to have been issued by Zimmer and little or no effort was made to inform consumers about the potential problems with Zimmer NexGen Knees that contained the recalled components.
Loose Zimmer NexGen LPS-Flex Knee
A second Zimmer NexGen knee recall was implemented in December 2010, but involved only a few hundred femoral components used in the NexGen Complete Knee Solution LPS System and the NexGen LPS Flex Gender System. These products were recalled because of a manufacturing flaw in certain lots that exhibited a nonconforming internal CAM radius, i.e. nonconforming geometry.
Zimmer had become aware of problems with these components in September 2010, and sent an “Urgent Device Correction and Removal” notices to distributors, sales staff, risk managers, and implanting surgeons in the U.S., Germany, Spain, France, the U.K., Italy, Sweden, South Africa, the Czech Republic, Bulgaria, Poland, Romania, and Austria. Sales staff and risk managers were instructed to return any product on hand. Surgeons were informed of the issue but there was no action to be taken by them.
The FDA’s quietly issued Class II recall for these subsets of femoral components, several months after the problems were identified by Zimmer, did very little to alert the consumers of their potential problems. Again, Zimmer never notified its customers, nor issued any type of press release to the general public.
Problems with Zimmer’s NexGen systems continued to surface. The British Journal of Bone and Joint Surgery published the 2007, peer-reviewed findings of three professors at the Department of Orthopedic Surgery at Seoul National University College of Medicine, H. S. Han, MD, S.B. Kang, MD, and K. S. Yoon, MD, entitled, “High Incidence of Loosening of the Femoral Component in the Legacy Posterior Stabilized Total Knee Replacement.”
The article stated that 38 percent of the patients in their study of 72 NexGen LPS-Flex Fixed Total Knee replacements in 47 patients implanted by a single surgeon between March 2003 and September 2004, had loosening of the device in less than three years and 21 percent required surgery to correct the problem in less than two years.
According to the professors, they had “not previously experienced such a high rate of early loosening for any design of TKR (Total Knee Replacement). Two subsequent studies reported in the same journal, one in 2008 and another in 2010, showed similar results of premature loosening of the NexGen LPS-Flex Knee.
Zimmer Knee Implants
Should Zimmer NexGen CR-Flex Be Recalled?
Dr. Richard Berger, a former Zimmer consultant who taught doctors how to implant Zimmer’s knee devices, contends that a recall of Zimmer’s NexGen CR-Flex is in order. His 2010 study with colleague Dr. Craig Vella concluded a recall was in order, given a high rate of revision surgeries during the first two years after the device was implanted.
Their recommendation was watershed moment for both Zimmer and Berger. It was learned later that Zimmer had paid Berger about $8 million over a decade for his consulting services, including instruction of doctors on how to implant Zimmer knees.
By 2005, in fact, Berger had implanted 125 uncemented CR-Flex Knee devices in patients. But within a year he advised Zimmer that X-rays suggested signs of loosening because the porous femoral component was not fusing completely to the bone, as the company had indicated it would. Although patients were able to walk, they experienced severe pain.
And by 2007, Berger had stopped using the replacement entirely and reported that several other surgeons had also experienced problems with it.
Despite the conclusion of the study, Zimmer stood behind its product and turned down Berger’s request to pull its NexGen CR-Flex from the market. In fact, it pointed a finger at its longtime consultant. It suggested any problems were not the result of poor product design, but rather of faulty surgical procedures and techniques utilized by Berger and others who questioned the effectiveness of the implant.
In backing up its claims, the company cited the NexGen CR-Flex Porous component’s strong track record of clinical success in Australia. In a Securities and Exchange Commission filing from March 2010, Zimmer responded to the Berger/Della Valle study by citing statistics from the 2009 Australian National Joint Replacement Registry report. It reported:
“Of the 7,100 implantations using the NexGen CR Porous or NexGen CR-Flex Porous systems since 2004, revisions were reported for 120 patients, representing a revision rate of 1.7%, inclusive of all components and reasons for revision.
“The performance of the NexGen CR-Flex Porous Femoral component . . . demonstrates that it is a safe and effective product when used as indicated in the surgical technique.”
Zimmer also tried to minimize the damage done to its reputation, claiming that “sales of the NexGen CR-Flex Porous component only represented approximately 2 percent of the company’s knee revenues in 2009.” However, a New York Times article in June 2010 thrust the contentious dispute between the company and Berger into the national spotlight. A month later, Sen. Charles Grassley (R-Iowa) issued a public letter to Zimmer Holdings, questioning the company’s corporate behavior.
Sources:
- http://www.zimmer.com/en-US/pc/article/zimmer-knee-products.jspx
- “Zimmer Knee Replacement Problems” by Ronald V. Miller Jr. Downloaded from
- “Zimmer NexGen Knee Replacements Recalled” by Harvey Kirk. Downloaded from
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=92118&CREATE_DT=2010-09-13
- “Zimmer NexGen CR-Flex Knee Replacement” Downloaded from http://resources.lawinfo.com/en/Legal-FAQs/zimmer-knee-replacement/
- http://www.fcpablog.com/blog/tag/zimmer?currentPage=2
- http://www.nytimes.com/2007/09/28/business/28devices.html
- http://web.jbjs.org.uk/cgi/content/short/89-B/11/1457
- “High Incidence of Loosening of the Femoral Component in Legacy Posterior Stabilized-Flex Total Knee Replacement,” by H. S. Han, MD, S. B. Kang, MD, PhD, and K. S. Yoon, MD, PhD. Copyright © 2007 – Journal of Bone and Joint Surgery – British Volume, Vol. 89-B, Issue 11, 1457-1461.
