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Zimmer NexGen Knee Implant 9% Failure Rate, 36% Loose, 50% with Pain! - A Recall is Needed!

By Michael Monheit

For years, 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?'

Dr. Lawrence Dorr, a Los Angeles orthopedic surgeon, shares Dr. Berger's concerns that Zimmer's artificial hip was failing after only a few years.

Component of NexGen Line Recalled

The MIS tibial component is intended to promote Zimmer's so-called 'minimally invasive surgery.' A two to three inch incision is required compared to an eight to twelve inch incision. As such, many MIS components were implanted with traditional extender stems, which are used by surgeons to attach to the tibia. Zimmer claimed the MIS did not require an extender stem to anchor the artificial knee to the tibia.

The revision and failure rate of NexGen MIS was reviewed by two orthopedic surgeons in a 2010 study that compared surgeries that used extender stems versus those without. The study findings showed that MIS Tibias placed without a stem component failed 24 percent of the time compared to those with stem components which failed only 4.2 percent. Based on these findings, the U.S. Food and Drug Administration (FDA) issued a Class-II recall of the NexGen MIS in September 2010.

The agency has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.

At t his time, long-term performance of artificial hips and knees, a $6.7 billion annual business, is not tracked. And sadly, those with the most to lose are the hundreds of thousands of people who receive an orthopedic device each year.

Originally posted at InjuryBoard by Michael Monheit

Full post as published by Phoenix Personal Injury Lawyer on February 03, 2011 (boomark / email).