While that may not seem like a high number, consider the pain and suffering experienced by patients having received the Zimmer NexGen Knee Replacement system in good faith, and with an expectation for at least 15 good years of service from their appliance.In reality, for some, that expectation is dashed and replaced by circumstances surrounding an allegedly failing Zimmer knee. A NexGen lawsuit usually follows.
Going behind the headlines provides insight.
Historically, knee and hip replacement surgery was quite invasive, requiring hospitalization for several days and a long period of healing. However, the advent of minimally invasive surgical techniques, akin to that which involves the delivery of Zimmer Knee Replacement, afforded patients, in most cases, the chance to return home the same day as their surgery. This freed up hospital beds and other medical resources, and a much smaller incision meant the patient could convalesce more quickly and return to his or her daily routine in an expedited fashion.
But there have been well-documented problems with the NexGen CR-Flex Porous Femoral component, one of the products that comprise the Zimmer NexGen family of artificial joints. They have been alleged to fail far too early in some patients, and revision surgery is often required to address the failure and either repair what is wrong or replace the allegedly failed component with another - often, that of another manufacturer.
For the patient, a prematurely failing implant can mean months, if not years, of health challenges that can affect job performance or the ability to work at all. The market, and the demand for hip and knee implants such as Zimmer knee implants is huge, given that the largest single demographic in America - the Baby Boomer - is beginning to nudge retirement.
But that’s just part of the story. With Americans receiving hip and knee implants at a younger age while at the same time continuing to work past retirement and proving to remain more active than a previous generation, the need for an implant such as the NexGen CR-Flex to deliver the expected 15 years of trouble-free service is paramount.
And when such an implant goes wrong, the fallout is exacerbated when the patient is younger, perhaps still working and certainly more active.
This reporter has a neighbor who received a knee implant in his mid-fifties after suffering from pain and mobility issues for several years. He hung on as long as he could, but his pain and mobility challenges were affecting his lifestyle and the ability to perform his job.
He opted for knee replacement, and was off work for several weeks to convalesce. So far, after a year, his knee implant is holding up and he has resumed his active lifestyle - which includes a lot of golf on weekends - and his job.
It is not known if he has a Zimmer NexGen Knee. But I can imagine his suffering if circumstances befalling some Zimmer knee patients fell to him. Pain and mobility issues akin to the original failure of his natural knee would resurface with a failing Zimmer NexGen. He would then require additional surgery to address the allegedly failing component, and perhaps have it replaced.
In most cases, revision surgery is far more complicated than the initial procedure and is usually more invasive, requiring even more convalescent time off work. The older the patient, the longer it can take to heal. And for patients without benefit of an understanding employer, job loss is always a possibility.
Health advocates have lobbied for a Zimmer knee replacement recall of the Zimmer NexGen CR-Flex system or components. To date this hasn’t happened, save for a recall over two years ago of various components associated with the Zimmer NexGen Complete Knee Solution LPS.
Zimmer is digging in its heels, maintaining its products are safe and effective if implanted properly, and have faulted surgeons for errors. Surgeons, in turn, claim Zimmer has a faulty design.
Complicating matters even further is the continuance of an FDA (US Food and Drug Administration) regulatory loophole that allows new medical devices that are substantially similar to medical devices already approved and successfully used in the market to escape the normal regulatory vetting reserved for new products. In this way, an existing product (hip and knee implants) featuring a new design, or a new surgical technique, is fast-tracked to market in an effort to make the new device available to patients faster.
It also saves the manufacturer from costly clinical testing and allows for the introduction of a new revenue stream much sooner. Manufacturers can’t be faulted for taking advantage of a regulatory gift provide by the nation’s drug and medical device watchdog, the FDA. Many health advocates are critical of the fast-track loophole, and are associating the failures of several newer devices - such as hips and knees - to inadequate vetting.
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As with Zimmer Knee Replacement, newer may not always be better. Patients may well prefer to stick to older, more traditional implants delivered via a more heritage-based, invasive surgical technique. Healing time is longer, but chances appear better that a 15-year lifespan of the implant will be achieved.
As for recipients of Zimmer NexGen Knee Replacement, there is sufficient debate over the efficacy of newer implants and surgical techniques to consider a NexGen lawsuit, especially if an implant has allegedly failed prematurely, and has produced pain and suffering far too early in the expected lifespan of the product. And given the issues, a qualified NexGen Knee attorney conversant with the portfolio to represent you is vital.