Zimmer is the world’s largest knee replacement implant producer. The Indiana-based company controls 26 percent of the knee replacement market, according to DrugWatch.com and has sold more than 3 million of its popular NexGen knee replacements since they were introduced in 1995.
The company was founded in 1927 and developed its first total knee replacement product in 1968. The manufacturer has had trouble with several of its knee replacement products and devices, which have been the focus of several recalls issued by the U.S. Food and Drug Administration (FDA).
Zimmer knee products that have been problematic and the focus of recalls include the NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays and the MIS Modular Tibial Plates and Keels. All of these products were recalled in September 2010.
In addition, the NexGen LPS-Flex Gender Femoral Component was recalled in December 2010.
The Natural-Knee II Durasul All-Poly Patella was the focus of a Class II FDA Recall on Jan. 25, 2012
Zimmer Knee Devices and Products – Complications and Concerns
Zimmer knee devices and components have been among the more problematic products on the market for a variety of reasons. To date, they’ve required higher than normal surgery revision rates because of such problems as loosening. Loosening is one of the more common problems associated with knee replacement devices and products – it occurs when parts of the implant begin to separate from the bone.
The FDA has received hundreds of reports of problems tied to Zimmer devices loosening. This problem is particularly associated with Zimmer’s NexGen CR-Flex uncemented knee. Designed to encourage a patient’s bone to grow and fuse with the device, the components have done just the opposite, according to many reports. Within a year of surgery, the NexGen CR-Flex components loosen, causing the patient pain and discomfort, according to DrugWatch.com
In addition to concerns surrounding the loosening of Zimmer’s knee devices and components, patients who have Zimmer implants have reported feeling as if they are victims of high failure rates stemming from design flaws.
Still other issues include patients feeling as though they’ve been misled by Zimmer’s advertising about product safety. In this case, patients feel the company conceals the adverse effects of its products, according to DrugWatch.com
Recalls of Zimmer Knee Devices and Products
Some of the recalls, warnings and statements issued over the years for Zimmer knee devices and associated products include:
NexGen Complete Knee Solution MIS Tibial Components; NexGen TM Tibial Trays and the MIS Modular Tibial Plates and Keels – Class II Recall
The FDA posted a worldwide recall for all of these components in September 2010. Much of the problem was based on complaints of loosening of the implanted devices. The loosening triggered the need for revision surgery. As part of these recalls, Zimmer sent an “Urgent Device Correction” letter on April 26, 2010 to all customers.
The MIS Tibial Component, in particular, was the focus of an “Urgent Field Safety Notice” and “Urgent Device Correction” letter distributed in April 2010 by the manufacturer – which led to the FDA recall of the product. In this case, Zimmer admitted that part of the problem with the MIS Tibial Component design was that “MIS procedures are inherently challenging and can involve reduced visibility, which may lead to difficulty in achieving proper implant alignment and cement fixation.” The company nevertheless marketed this defective product and surgical technique, according to DrugWatch.com. As a result, a number of the implants loosened and patients were forced to have revision surgeries.
Zimmer NexGen LPS Flex Gender – Class 2 Recall
This worldwide recall, posted by the FDA on Sept. 13, 2010, was also due to loosening of the device, according to the FDA website. The loosening devices ultimately required that the patient undergo revision surgery and device replacement. At the time of the FDA notice, 114 reports of this problem had been filed.
Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm – Class II Recall
This was yet another worldwide product recall. It was issued in January 2012 and was based on the product failing.
Zimmer Knee Lawsuits
More than 700 lawsuits have been filed over complications and complaints surrounding Zimmer’s products, according to DrugWatch.com. Because of the high number of lawsuits, they have been consolidated in the U.S. District Court of Northern Illinois under the multidistrict litigation (MDL) case number 2272.
Zimmer knee devices have been tied to a variety of problems, including:
- Increased pain
- Premature failure
When such problems occur, it often requires costly revision surgery.
Should You File a Claim? How do you know if you have a problem?
If you have experienced, or are currently experiencing any of the following issues, you should seek medical attention. In addition, you may want to consider speaking with an attorney about your legal options and filing a claim:
- Difficulty walking or standing
- A loose feeling in the knee
- Persistent knee pain or swelling
- Need for revision surgery
- Popping, crunching or clicking noises in the knee
Additionally, patients who have already endured the pain and inconvenience of a failed or defective knee replacement or underwent the expense and suffering of revision surgery, should consider filing a lawsuit against the device manufacturer. Filing suit may be the only way to obtain compensation.
If You’ve Been Seriously Harmed – Estey & Bomberger Can Help
Estey & Bomberger is a nationally recognized product liability law firm. In the past five years alone we have won more than $100,000,000 in settlements and verdicts for our clients. You may be entitled to a variety of compensation as a result of a defective or faulty knee device or component. The types of compensation available in such cases include:
- Damages for medical expenses, both past and present
- Costs for rehabilitation and/or home health care
- Costs for lost income
- Damages for permanent disability
- Damages because of pain and suffering
Call us to arrange a free consultation. Estey & Bomberger’s expert product liability attorneys will review your case. We work on a contingency basis, which means you only pay if we recover money for you.