As knee implant attorneys, we are blogging on the Zimmer NexGen knee replacement component which was the subject of an FDA recall . This is the first in a series of posts providing information regarding some of the Zimmer knee implant component parts. We hope these posts will be helpful to any knee replacement patient.
Zimmer Knee Background
On September 13, 2010, the U.S. Department of Health and Human Services Food and Drug Administration issued FDA Recall No. Z 2409 010 entitled “NexGen Complete Knee Solutions MIS Tibial Components, Locking Screw and Stem Extensions” recall notice. This recall notice can be found at the FDA website.
This latest Zimmer recall was one in a series of knee joint replacement hardware recalls issues by the FDA. Zimmer’s track record over the years had been very good. However, this potential component problem is concerning to the medical community.
Given the sheer volume of knee implant patients who have had joint replacement surgery, it is fair to ask whether risks associated with knee implant surgery outweigh the benefits. This is the first in a series of posts that will discuss the evolution of knee replacement surgery in an effort to answer this question. We hope that this discussion may have particular interest to all patients who have had knee implant surgery whether or not the surgery involved the recalled Zimmer knee implant component.
History of Knee Implant Surgery
Knee replacement surgery was pioneered back in 1954 by surgeon L. G. P. Shiers. Research shows that Dr. Shiers was a true patient advocate and actually refused to patent his knee replacement technology. In doing so, Dr. Shiers gave up what could have been millions of dollars in royalties from the future sales of knee replacement technology. Instead, he traveled the world, teaching knee replacement surgery to other orthopaedic surgeons and medical students so they could pass on the benefits of knee joint replacement surgery to any patient who needed a knee replacement.
Knee replacement surgery, following the success and failures of hip replacement surgery, became more commonplace in the 1960s and the 1970s. It was billed as safe, effective, and an enormous benefit to any patient with osteoarthritis. Since that time, as with hip replacement surgery, knee replacement joint technology is constantly changing and modifying in an effort to improve patient outcomes in knee replacement patients.
Throughout the years, there have been many knee replacement part manufacturers (Zimmer, Stryker, DePuy, etc). These joint replacement manufacturers and others constantly compete to try and develop the “latest and greatest” knee implant components and techniques. The one constant challenge to all of these knee replacement manufacturers has been to limit the inevitable problems of implant loosening, wear and tear of the implant parts, and loss of the natural range of motion. As with all joint replacements, there still is not any suitable replacement for the body’s own anatomical structures.
Since the innovation of knee replacement surgery, there have been hundreds of thousands of patients who have undergone knee replacement surgery involving different techniques and various artificial knee components. Unfortunately, with each new “innovative” technology, there always is the potential for possible hardware failure problems, which could cause the patient to develop a new set of symptoms that conveniently replace the old ones. As a result, many patients who have undergone knee replacement surgery and have been subjected to these problems are left to wonder whether the surgery was worth it.
Knee Implant Attorneys in New Jersey and Philadelphia
If you have recently undergone a knee replacement surgery and your recovery process is taking far longer than expected, you may want to find out if there is a problem with your knee replacement. Contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
For more information regarding the knee replacement concerns, visit the Mininno Law Office site dedicated solely to Zimmer knees.
Recent news demonstrates that not only are DePuy recall lawyers and patients planning for the litigation, but Johnson & Johnson and DePuy have also recognized the potential problem and have taken financial steps to prepare themselves. According to Johnson & Johnson’s fourth quarter earnings report released this past month, the company is taking a $922 million charge related to its potential exposure for the DePuy hip recall. While $922 million may sound like a large sum of money, it may be inadequate to cover the sum of 93,000 potential claimants that will require compensation from Johnson & Johnson.
As a 
For years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.
In fact, some hip replacement surgeons have argued that hip implant and joint replacement surgery is one of the most important surgical advances over the last century. Because of its popularity, and potential profitability, hip manufacturers such as DePuy, Johnson & Johnson, Zimmer, and others have been competing to capture this potentially lucrative market. Unfortunately, as has been suggested with DePuy, sometimes manufacturers are in such a rush to roll out a “new and improved” implant device, they fail to properly test whether the hip, knee, or other joint implant is better than those that already existed on the market.
Recently, the prestigious Washington Post reported on a fairly widespread yet rarely discussed practice of medical device sales representatives to lurk in operating rooms, without patient knowledge or approval, and guide surgeons in the surgical procedure. According to the Washington Post, this practice of sales rep “assistance” is common among medical device companies including Johnson & Johnson, Stryker, Zimmer, and DePuy.
Under this system, all DePuy hip recall patient should have a specific medical record in their chart which will show which DePuy hip implant products where used. Specifically, for DePuy hip recall patients, there should be a label taken directly from the package that was opened up in the operating room and affixed in the chart. This DePuy label should identify the DePuy hip replacement system (e.g. ASL XR, Pinnacle, etc), the model number, and serial number for the DePuy hip implant.
Despite this responsibility, the FDA has not done much regarding the recall since July 17, 2010, the date they posted information on specific recalled devices. The recall contained DePuy 
Judge Katz will be a welcome addition to the multi-district litigation of DePuy hip recalls. This is not the first time that he has handled a complex MDL. In the past, Judge Katz presided over litigation involving the contraceptive Ortho Evra. In that matter, the Judge received favorable approval ratings from both the defendants and the plaintiffs who brought the claim. In addition, Judge Katz’ background makes him an ideal candidate for DePuy hip recall litigation. 
Bob Lugton, of Brisbane, Australia, was declared the first “Aussie” to join the DePuy hip recall lawsuit. Mr. Lugton filed suit when his DePuy hip implant failed only 18 months after having been implanted. As stated in previous posts, DePuy and Johnson & Johnson claimed that their hip implant would last as long as 20 years, so Mr. Lugton was a very unhappy man after his brand new hip failed so quickly. Like most DePuy hip recall patients, Mr. Lugton was also found to have cobalt and other metals leaking into his body from the wear and tear of his hardware. When asked why he joined the DePuy hip recall lawsuit, Mr. Lugton reportedly stated, “This is not for financial reasons”, but to let other people know of the devastating effects of toxic cobalt and chromium levels on his health and welfare.