On March 12, 2015, the Food and Drug Administration (FDA) followed up on the voluntary recall by the Zimmer company of what it considered to be Zimmer tibial plate failure in its Persona knee prosthetic unit.

The company had voluntarily recalled the tibial plates in February of the same year, an action affecting domestic and global distribution of approximately 11,700 units.

The FDA issued a Class 2 Medical Device Recall for the Zimmer tibial plate failure, a type of recall that is reserved for devices where the risk of serious injury and death from its use are present but not necessary immediate. This is an intermediate level classification, as there are Class 1 and Class 3 recalls, with Class 3 being the least serious. Class 2 recalls are somewhat preventative, and the FDA assists the manufacturer with alert communications.

The Zimmer tibial plate failure was identified in the device recall as occurring because of radiolucent lines. These lines are marks on an X-ray that indicate the plate may be coming loose from the bone. The recall also clearly states that there are complaints regarding loosening along with the radiological evidence.

The tibial plate sits on top of the tibia, the major leg bone of the lower leg, and it provides a platform upon which the plastic meniscus and femoral component can articulate and move.

The plate has a stem which is implanted into the bone without cement and is supposed to grow into surrounding tissue for stabilization. The Zimmer tibial plate failure, as identified by the radiolucent lines and complaints of loosening, indicates that that stabilization or growth into the lower leg bone process didn’t go as planned.

What is the Problem with Radiolucent Lines?

So, with the Zimmer tibial plate failure, the radiolucent lines indicate gaps between the components of the prosthetic and the bone. These gaps can fill up with intercellular fluid causing severe inflammation and pain. The gaps can also fill with wear debris from the prosthetic, which has led to similar complications with many metal-on-metal joint replacement products.

As the wear debris sits in the gaps, it can cause bone damage and bone tissue loss which may be permanent. The problem with bone tissue loss is that it could make it more difficult to sustain a second prosthesis after early revision surgery is performed.

Zimmer’s Recall History

The Zimmer Company, headquartered in Indiana, has made a countless number of joint prosthetic systems. It has also experienced more than its share of failed units and components. Among products that have been recalled by the company are the Durom Cup hip component, MIS tibial components, and NexGen Knee models.

What are the Signs of Knee Prosthetic Failure?

With the Zimmer tibial plate failure or other prosthetic failures, there is usually persistent pain and inflammation associated with “fixed” knee. This can be confusing in that it can resemble the pre-condition that resulted in the total knee arthroscopy in the first place – degenerative arthritis or trauma to the joint – and many patients might want to dismiss it as phantom pain.

Other symptoms to be on the lookout might be a feeling a global tightness around the joint or general instability, like the knee might give out underneath you.