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On March 12, 2015, the Food and Drug Administration (FDA) issued notice of a Class II Recall of Zimmer. Inc.'s Persona Knee implant. Zimmer voluntarily recalled the product due to a high volume of consumer complaints. The FDA issues a Class II Recall when a product can cause temporary or medically reversible adverse health consequences.
The Zimmer Persona Knee system is the company's newest knee implant and is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee system utilizes a modular design between the tibial plates and articular surfaces
Over 11,600 components of Zimmer's Persona Trabecular Metal Tibial Plate have been recalled. The most common issues are asymptomatic radiolucent lines and loosening implants that have resulted in revision surgery. A number of different sizes and lots of the product have been recalled. Patients who suffer complications related to this product may also experience:
- Persistent pain
- Knee instability
- Knee tightness
- Loss of mobility
Radiolucent lines are large gaps in between knee replacement components or between the components and the bone, which can be detected in x-rays and cause a number of problems. Joint fluid, tissue and implant-wear debris may lodge in the cracks, leading to bone damage called osteolysis. Osteolysis is an early indicator of implant failure. Loose implants can cause severe pain, swelling and tissue and bone damage.
Please call us today to learn more about your legal rights at toll free 866-292-1582 or submit an online email form.