On March 12, 2015 the U.S. Food and Drug Administration (FDA) announced a knee replacement recall involving the Zimmer Persona Personalized Knee System. The reason given for the recall is “[a]n increase in complaints of loosening and radiolucent lines,” that can potentially result in the need for replacement of the device though a process called a revision surgery. Attorneys note that the FDA approved the recalled Zimmer knee replacement system for use in December 2014.
If you or a loved one received a Zimmer Persona knee replacement and would like more information about your options, contact Attorney Group today. We offer free, no obligation consultations, and if you have a case we can connect you with an affiliated medical device recall attorney who can assist you with your claim.
Urgent Recall for Zimmer Persona Knee Replacements
The FDA recall notice states that the Zimmer knee replacement recall is being given Class 2 status, meaning that the device poses the danger of causing adverse health conditions if used. 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.
Over 11,000 units of the Zimmer Persona knee replacement system are reported to have been distributed worldwide and in the U.S., including in the states of 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 affected states were specifically included in the recall notice.
Zimmer Persona Knee Replacement is a 510(k) Approved Product
The recalled Zimmer knee replacement system was approved in December 2014 using the FDA’s 501(k) procedures. Attorneys note that under this controversial approval process, medical devices may be cleared for sale if they are demonstrated to be “substantially similar” to another medical device that has been approved under the FDA’s more rigorous Premarket Approval, or PMA, process. The PMA process requires a demonstration of a product’s safety and effectiveness in clinical trials before that product is approved for sale. Devices approved under the 501(k) process do not require such testing—only that they are similar to devices that have passed the PMA process.
Knee Replacement Recall Follows Hip Replacement Lawsuits
The recall of the Zimmer Persona knee replacement system follows ongoing litigation related to hip replacement systems sold by the company, in addition to lawsuits related to the M2a Magnum hip replacement systems sold by Biomet, another medical device manufacturer recently purchased by Zimmer, and other metal on metal hip replacement systems. Like the recalled Zimmer knee replacement system, metal on metal hip replacement systems have been linked to risks of early device failure. In February 2014, Biomet agreed to pay approximately $56 million to resolve injury claims related to its M2a Magnum hip replacement system.
Have Questions About Your Knee or Hip Replacement System?
If you have questions about the Zimmer Persona knee replacement recall, or if you or a loved one has suffered injury as a result of a knee replacement or metal-on-metal hip replacement system, contact Attorney Group today. We can help answer your questions in a free, no-obligation consultation. If you decide to pursue a claim, we can connect you with an affiliated medical device recall attorney who can assist you through the legal process. The time to file a lawsuit is limited, so contact us today.