The FDA announced a recall of one of the many Zimmer knee replacement implants that are on the market.
On March 12th, 2015, the FDA announced a class 2 recall of the Zimmer Persona Trabecular Metal Tibial Plate/Persona TM Tibia. The recall applies to all of the sizes and lots of the Persona knee line that are currently on the market. It is believed there are over 11,000 Persona devices in use right now.
FDA Class 2 Recall
The FDA issues a Class 2 recall when a device “may cause temporary or medically reversible adverse health consequences.” This means it can cause harm to an individual but the harm is fixable. In the case of the Zimmer Persona knee line, it was recalled because of complaints of various components loosening. When the implant loosens, it may cause significant pain for the patient and result in secondary surgery to fix any problems.
The loosening of the Persona product line is counter to its claim of having a superior and more accurate fit. The Zimmer Persona implants are a type of modular knee prosthesis designed to resurface the articulating femoral, tibial and patellar bones. The implant is designed to fit without any cement/glue thus allowing for a more accurate fit. However, when the various parts loosen, this creates gaps between the bone and the implant. The body then looks to fill those gaps with water, fluid, tissue, or debris, which leads to pain, infection, bone damage, and osteolysis.
The FDA’s recall announcement comes after Zimmer sent an urgent medical device recall notice to hospitals and doctors across the country on February 2015, warning them of the impending voluntary recall and advising them that “all affected products are to be located and quarantined immediately.” Over 11,000 knee parts are expected to be recalled.
Our Defective Zimmer Knee Lawyers Can Help
Our dangerous device attorneys can help if you or someone you care about was harmed by knee replacement surgery. Lawsuits have been filed against the device makers by both patients and their families seeking compensation for injuries caused by the dangerous devices. You may be entitled to a settlement. We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you. Our defective knee lawyers will help you file your lawsuit.
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Our knee replacement lawyers will help you file your lawsuit. To get started, you can:
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