A Class II recall has been issued for the Zimmer Persona Personalized Knee System after it was linked to reports of “loosening and radiolucent lines,” which could require the need for revision surgery.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after undergoing knee replacement surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Zimmer Inc. and we can help.
Zimmer Persona Knee Recall
Zimmer Inc. introduced its Persona Knee System in late 2012 as a “new era of personalization” for artificial knee replacements, and as the “… most clinically successful knee replacement more personalized than ever.” Unfortunately, less than 3 years later after it hit the market, Zimmer issued a worldwide recall for all sizes and lots of Persona tibial knee plates. The tibial plate is one component of the Persona knee replacement system.
The Class II recall was issued after an unacceptably high number of patients reported experiencing loosening of the knee and an increase in radiolucent lines on x-rays that indicate a gap between the metal plate and the bone. “Radiolucent” means it shows up as dark areas on an x-ray, which indicates less bone density in the knee. All sizes and lots of the Zimmer Persona Trabecular metal tibial plate are affected by the recall, and should not be used in any future knee surgeries. Class II recalls are reserved for products that can “cause temporary or medically reversible adverse health consequences.”
According to the FDA:
“Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately.”
How Many Products are Affected?
About 11,600 units of the Zimmer Persona knee replacement system have been distributed worldwide, according to the FDA. The devices were distributed to U.S. states including Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin. Certain Veteran Administration hospitals in these states were specifically included in the recall notice.
Zimmer Knee Complications
The problems with Zimmer Persona Knees stem from poor seating or fixation, which can cause knee replacement patients to experience the following complications:
- Knee Pain
- Knee Replacement Loosening
- Lack of Artificial Knee Fixation
- Device Failure
- Need for Revision Surgery
Zimmer says the complaint rate associated with the Persona knee is higher than expected compared to similar devices, acknowledging that about 6 out of every 1,000 implants may fail. However, some critics suggest that the risk of complications may be much higher the longer the implants remain implanted.
Persona Knee Approved Via FDA’s 510(k) Loophole
The Zimmer Persona knee replacement was cleared for sale on the U.S. market through the FDA’s 510(k) approval loophole. Under 510(k), medical devices may be approved if they are “substantially equivalent” to existing devices cleared via FDA’s more rigorous Premarket Approval (PMA) process. PMA requires demonstration of a product’s safety and effectiveness in clinical trials before it can be approved for sale. Devices approved under 510(k) do not require such testing—only that they are similar to products that have passed the PMA process.
I had a knee replacement that had to be revised, but I don’t know what company made the implant. How do I know if I have a lawsuit?
The first step in determining whether you have a lawsuit against the manufacturer of a hip replacement is to find out which device you were implanted with. Hospital records contain this information.
Other factors that need to be considered are what caused the need for a revision surgery, and how much time has passed since the original knee replacement. Successful joint replacements should last 15 to 20 years. If you required revision surgery before the expected life span, there is a possibility that your device may have failed prematurely.
Can I Participate in a Class Action?
To date, no class action lawsuit has been filed over injuries alleged from the Zimmer Persona knee. However, this doesn’t mean you’re out of luck if you’ve been injured. Our lawyers are currently filing individual lawsuits on behalf of injured parties. If we determine that you have a valid claim, you could be entitled to compensation to assist with medical expenses, lost wages, pain and suffering, and other damages.
Need More Info?
If you’d like more information about these topics, please visit our Zimmer Persona FAQ page.
Do I Have a Zimmer Persona Knee Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zimmer Persona Lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one suffered complications after knee surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.