If you are a recipient of the Zimmer NexGen knee replacement and are questioning its stability, safety, or reliability, you are not alone. The Zimmer NexGen CR-Flex product has proven problematic in an increasing number of total knee replacement patients, several of whom have opted to file a lawsuit against the manufacturer of this product.
If you have suffered any of the following side effects or adversities as a result of your experience with the NexGen knee implant, the experienced Zimmer knee attorneys of Eisbrouch Marsh can help review your claim, offer guidance, and get you started on your Zimmer knee replacement lawsuit.
Reported Zimmer knee complications include:
- Painful joints
- Infections in the knee area
- Nerve damage
- Bone fracture or loss
- Limited range of motion
- Difficulty walking or standing
If the above-listed side effects are familiar to you, and you are one of the 500,000 orthopedic patients having received a Zimmer knee replacement, you may have a claim for financial compensation under the laws of negligence, product liability, medical malpractice, or even breach of warranty. For help determining the direction of your claim and the proper course of action to pursue, we encourage you to contact a product liability lawyer at Eisbrouch Marsh right away.
History of Zimmer Knee Products
Knee replacements are hardly a new arrival on the American medical product market – with many models emerging as early as the 1970s. Thereafter, Zimmer began introducing its knee replacement products to the market, followed by its NexGen series in the mid-1990s. Despite increasing criticism from patient advocates, many of Zimmer’s products were “fast-tracked” through the FDA testing procedures under Section 510(k) of the Food, Drug and Cosmetic Act.
Section 510(k), also known as “Pre-Market Notification,” is a procedure wherein a derivative of a previously-approved medical device can receive FDA approval for sale and use with patients despite not having endured full FDA testing and research. Within the purview of total knee replacement devices, the Zimmer NexGen CR-Flex is one of several Zimmer products having received a fast-tracked approval from the FDA, potentially exposing hundreds of thousands of orthopedic patients to a dangerously unstudied medical device.
Concerns over the Zimmer NexGen CR-Flex
The Zimmer NexGen CR-Flex, despite receiving a fast-tracked approval for sale by the FDA, has not gone without scrutiny – a non-peer reviewed report by Dr. Richard Berger of the American Academy of Orthopedic Surgeons was cited in the New York Times as exposing the potential dangers of this surgical implant.
According to his report, entitled “The High Failure Rate of a High-Flex Total Knee Arthroplasty Design,” Dr. Berger expressed concern over the CR-Flex model after studying 108 patients and finding the following:
- 36 percent of patients showed signs of radiographic loosening
- 8.3 percent of patients were in need of revision surgery within two years of the original implantation
- One percent had a revision surgery pending
More specifically, Dr. Berger expressed concern over the porosity of the CR-Flex model, which uniquely does not use cement to adhere to the patient’s bone. Dr. Berger concluded that the NexGen knee had a tendency to disengage once implanted in patients, eventually coming loose, negatively impacting patient mobility and quality of life.
According to reports from patients, the Zimmer NexGen CR-Flex model is associated with any of the following problems:
- Overall loosening of the components within the knee replacement system
- Fracture or dislocation of the implant
- Release of debris due to wear and tear
Medical interventions necessary to correct the problems allegedly caused by the Zimmer NexGen CR-Flex model have varied, and range in severity, invasiveness, and recovery time.
While it may be possible for some patients to avoid the hassles of a major follow-up procedure, an alarmingly high number of patients have needed revision surgeries, including a complete replacement of the knee implant.
Knee Replacement Recalls
Despite the widespread issues reported with the Zimmer NexGen CR-Flex model knee replacement product, the FDA has not issued a general recall of the product. However, the FDA has taken notice of several potentially problematic Zimmer knee components, including:
- NexGen MIS Tibial components: Voluntarily recalled by Zimmer
- NexGen LPS System: Only a few hundred recalled by Zimmer due to possible manufacturing defects
- NexGen TM Tibial trays
- NexGen Modular Plates and Keels
Pursuing a Lawsuit
If you are ready to pursue your dangerous medical device lawsuit, you will undoubtedly be best-served by working with a Zimmer knee attorney from start to finish.
In addition to providing steady advice and counsel throughout the duration of your claim, a Zimmer knee lawyer at Eisbrouch Marsh will help you by:
- Drafting your complaint against responsible parties, including filing and defending against motions to dismiss
- Gathering evidence to support your claims through the applicable rules of discovery
- Working closely with you to determine if a settlement with the defendant will be possible
- Insulating you from the intimidation tactics of the large medical device companies
- Litigating your claim in a trial, if necessary
- Filing appeals on your behalf, if necessary
A Zimmer knee lawsuit can help you recover some of what you lost as a result of a faulty medical product. For instance, if you had to miss weeks of work – or were forced to pursue total or partial disability benefits – your Zimmer knee lawyer can help you recover these lost wages. In addition, your lawyer can help you obtain restitution for your medical expenses, pain and suffering, and any other financial harm incurred due to the Zimmer knee product.
If you are considering a Zimmer knee injury lawsuit, you are in good company. There are currently over 1,200 Zimmer knee cases pending before Judge Rebecca Pallmeyer in U.S. District Court for the Northern District of Illinois.
Contact Our Law Firm Today
If you were injured followed the implantation of a Zimmer NexGen CR-Flex model or other Zimmer knee replacement product, we encourage you to contact a Zimmer knee attorney at Eisbrouch Marsh right away. You can schedule your free, no-obligation consultation with a personal injury attorney by calling 201-342-5545.
- New York Times, Surgeon vs. Knee Maker: Who’s Rejecting Whom? http://www.nytimes.com/2010/06/20/business/20knee.html?pagewanted=all&_r=0
- GPO.gov, US Code, https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360.htm