Some reports of patients who suffered from Zimmer knee implant failure say the complications were severe enough that they required revision surgery to remove and replace their Persona implant.

The Zimmer Persona knee replacement system is a knee prosthesis that is used in treatment for serious knee problems. It’s been used to relieve pain and mechanical problems related to conditions such as collagen disorders, rheumatoid arthritis, osteoarthritis, post-traumatic loss of joint configuration, and previous failed attempts to fix the knee.

The system is composed of a tibial plate component and articular surfaces. It’s made and marketed by Zimmer Biomet, an orthopedic device manufacturing company that is headquartered in Warsaw, Indiana. The function of the Zimmer Persona knee system is to resurface the articulating surfaces of the tibial bone, the patellar bone, and the femoral bone.

Unlike other knee implant systems, the Zimmer Persona was designed with a tibial plate that could be attached to the lower leg without the use of cement. Instead, the plate has two pegs that insert into the bone. The pegs were designed so that over time, bone growth next to the pegs would secure the implant in place.

Zimmer Biomet announced a voluntary recall of the Zimmer Persona tibial plate in February 2015. The FDA announced this as a Class II recall in March 2015, due to reports of loosening and radiolucent lines. Radiolucent lines appear in X-rays when the Zimmer Person knee replacement begins to loosen up. Spaces or gaps start to appear between the inserted implant and the bone. When the condition arises, the term is known as “poor seating.”

From the patient’s perspective, these problems might manifest with symptoms like pain, joint tightness or instability, loss of mobility, or inflammation.

Loosening and poor seating because of Zimmer knee implant failure may lead the patient to need revision surgery. Although revision surgery may relieve complications and adverse health effects resulting from the device’s implantation, revision surgery does come with its own set of risks and complications — generally more than are associated with the original knee implantation. Some of these complications and risks include pain, fractures, bone loss, blood clots, infection, and prolonged recover time.

When the Zimmer Class II recall was announced, medical communities, including hospitals, and physicians were notified. They were asked to quarantine all Zimmer Persona knee replacement devices and to complete an inventory Return Certification. This completion was to be completed prior to the shipping and return of the medical device back to Zimmer.

The recall had also included all lots and sizes of the Zimmer Persona knee replacement system and included the C0J Left and Right, and uncemented Trabecular Metal Tibial component. In all, about 12,000 units that had already been distributed were affected by the Zimmer Persona tibial plate recall.