By Andrew Sullo
Sullo & Sullo LLP
HOUSTON — Since 2003, more than 150,000 Zimmer NexGen CR-Flex knee implants have been sold, and an unprecedented number of patients who received the artificial knee system have experienced loosening, pain and other severe complications.
The Zimmer NexGen CR-Flex knee system uses a porous, non-cement femoral component that attaches to the bottom of the thigh bone. In most knee replacement systems, a type of surgical cement is used to hold the component in place.
A recent study presented at the 2010 conference of the American Academy of Orthopedic Surgeons provided evidence that indicated the Zimmer NexGen CR-Flex knee replacement failure rate could be as high as nine percent, and suggested that the number of Zimmer knee implant complications that required revision surgery could be even higher. The same study found that 36 percent of Zimmer NexGen CR-Flex knee replacements became loose within two years of implantation. However, Zimmer has placed the blame on operating physicians and claimed that failures were caused by surgical errors, problems with the installation technique, or incompatibility with the type of patient who received the knee implant.
The study’s authors, Dr. Richard Berger and Dr. Craig Della Valle who hail from the Rush University Medical Center in Chicago, examined nearly 110 patients who received the Zimmer NexGen CR-Flex knee replacements. They discovered that nine patients needed a second corrective surgery due to knee pain and implant loosening, and that nearly 40 recipients showed signs of loose Zimmer knee implants which were unrelated to patient type, procedural approaches or specific surgeons.
Dr’s Berger and Della Valle have since called for a recall of Zimmer’s NexGen CR-Flex devices, to no avail. This may have something to do with the fact that the NexGen products made up two percent of Zimmer’s $1.76 billion sales in 2009.
Since the Zimmer NexGen knee replacement system has been on the market, almost half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement , namely the NexGen CR-Flex, has recently been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, which then requires another surgery. As a result, some medical professionals have called for a Zimmer NexGen CR-Flex recall, though that has not yet happened. Zimmer NexGen lawsuits are now being reviewed by Zimmer knee attorneys for people who have experienced Zimmer knee replacement problems.
Zimmer NexGen Knee Implant 9% Failure Rate, 36% Loose, 50% with Pain! – A Recall is Needed!
Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings. But those days have long passed. Dr. Berger started complaining to Zimmer that one of its artificial-knee models was failing prematurely, and he recently went public with a study that proves it.
In fact, more than 150,000 Zimmer NexGen knee implants have been sold since 2003, many of which now require revision surgery.
One study, suggests that Zimmer NexGen high flex knees that are not cemented, are failing at a rate as high as 9 percent after less than two years. And, that 36 percent of implants were loosening. Over half of the 100 patients that were involved in the study experienced knee pain and other problems. Patients commonly experience – device failure, knee pain, revision surgery, loosening of the implant, compensation pain and problems.
In a letter to Zimmer Holdings (PDF), Senator Charles E. Grassley, addressed several concerns including, “What process does Zimmer have in place to respond to allegations and concerns raised by its consultants or contractors regarding the safety of one of its products?” Continue reading
Zimmer Inc. of Warsaw Indiana issued a recall of over 68,000 of their NexGen knee replacement products, according to the U.S. Food and Drug administration. The recall, originally posted in April of 2010, applies to “NexGen complete knee solution MIS total knee procedure stemmed tibial components” of sizes one through ten, says the FDA. In addition to the DePuy ASR recall, this recall highlights the increasing number of medical implant controversies involving a defective product.
According to the recall report, the knee replacement products were given to patients “with severe knee pain and disability” due to a variety of conditions, including several types of arthritis, knee trauma, anatomical deformities, and previously unsuccessful knee surgeries. The NexGen MIS Tibial Components and Tibial Plates and Keels were biologically affixed with bone cement, the FDA reports, though the TM Tibial Trays may have been used with or without this cement. Continue reading
Dr. Richard Berger, center, made millions working with Zimmer, an artificial-knee maker. The checks stopped after he spoke up about what he saw as flaws.
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