The Zimmer Persona Trabecular Metal Tibial Plate was recalled in March 2015. The recall was issued due to a higher-than-normal rate of loosening and other problems related to the implant. Some of the patients who received a Zimmer Persona Trabecular Metal Tibial Plate have developed osteolysis, or bone death. One of the many advances made in artificial joints is the development of porous, in-growth surfaces, which allows the surgeon to implement a cement-less fixation of the implant components. The porous surface allows the patient’s bone to grow into the artificial joint, in theory holding the device in place.
How Osteolysis Occurs
In the Zimmer Persona implant device, osteolysis can occur when there is a gap in the Persona components. This gap allows tissue, joint fluid or debris from joint wear to accumulate and can lead to radiolucent lines and the development of bone and tissue deterioration and death. There are some patient factors which can increase the chances of osteolysis following a knee implant, such as a high body mass index. High demand athletes as well as older patients may also see an increase in the development and severity of osteolysis. John J. Callaghan, professor in the University of Iowa’s Orthopedic Surgery and Biomedical Engineering Departments notes surgical technique is also crucial when positioning an artificial joint such as the Zimmer Persona.
While all these factors may play a minor role in the development of osteolysis, those who received a Zimmer Persona Trabecular Metal Tibial Plate have seen a much higher rate of bone loss, loosening and the necessity for revision surgery than patients with other types of knee implants. Treatment interventions for patients who develop osteolysis can be surgical and nonsurgical. Physicians will make the choice based on the severity of symptoms and the level of bone loss. For symptomatic patients, revision surgery is generally recommended. Patients who are experiencing osteolysis may have varying degrees of pain and inflammation, damage to the surrounding tissues, damage to the bone and tissue, immobility, difficulty walking or getting up from a seated position, instability or tightness in the knee, bone fractures and total implant failure.
More Than Forty Complaints Received for the Persona Trabecular Metal Tibial Plate
Prior to the recall in March, Zimmer sent an urgent medical device recall notice to hospitals and healthcare providers in February in which they were notified of the risks of the Persona Trabecular Metal Tibial Plate. Of the more than forty complaints received, more than a third suffered symptomatic radiolucent lines leading to revision surgery and twenty-eight percent had asymptomatic radiolucent lines.
The Persona implant device was advertised as a “personalized knee system.” With less than three years of sales under their belt, there are more than 11,500 of the Zimmer Persona implants in circulation. The recall of the Persona is a Class II recall, meaning there is a risk of “temporary or medically reversible adverse health consequences.” Zimmer is no stranger to product recalls, having recalled two different knee implant devices in 2010.
