A component of the Zimmer Persona knee replacement system has been under voluntary recall after reports of loosening.

The company announced a voluntary recall of the Zimmer Persona Trabecular Metal Tibial Plate in February 2015. The failed part is supposed to be secured in the body by the bone growing around two pegs intended to hold the implant in place.

The recall affects nearly 12,000 units of the Persona tibial plate, which is not secured with any type of surgical cement when implanted.

Two main complaints regarding the Persona tibial plate are:

• Radiolucent lines: Seen in X-rays, radiolucent lines are small gaps between the Persona tibial plate and the bone, indicating “poor seating.” These radiolucent lines are early signs the implant is loosening. Poor seating means the implant is moving from its intended position.
• Loosening: The Persona tibial plate can work loose from its original attachment because only bone growth secures it; no surgical cement is used with the tibial plate that has the two pegs designed to go directly into the bone. Zimmer claims a loose component “is one of the most prevalent causes for revision in total knee arthroplasty.”

Any loosening or poor seating can lead to further complications, such as fluid collecting around the joint. With nowhere to go, the fluid continues to build, causing joint pain and swelling while increasing the chances for infection to develop.

Persona Tibial Plate Failure Can Lead to Revision Surgery

Metals in the knee replacement implant may possibly wear down, causing tiny metal shavings to fall into the cracks between the Persona tibial plate and the bone.

In many instances, chronic pain and device loosening lead to revision surgery. When the Persona tibial plate’s pegs fail to generate enough bone growth, the pegs fail to hold the implant securely in place. Instability and patella tracking problems indicate the bone’s failure to develop its own secure connection to the tibial plate.

Enduring a second knee surgery is no small feat. A second knee surgery means more trauma for the joint. Patients are at a higher risk for pain and swelling, infection, bone clots, bone loss, tissue or blood vessel trauma, bone fractures, and nerve damage. The length of a patient’s leg can be affected by a second knee surgery.

Approximately 12,000 Persona tibial plates are covered in this Zimmer knee implant component recall. If your knee implant was set with cement, your implant is not affected by this particular recall notice.

If you’re unsure whether or not your knee implant contains the recalled Persona tibial plate, you can check an X-ray to see if pegs appear on the bottom of the metal plate that attaches to your tibia. If you still are not sure, a lawyer who has experience with knee replacement recalls can help you determine if your implant includes the recalled Persona tibial plate.