Zimmer Inc., an Indiana-based joint prosthesis manufacturer, is one of the largest makers of prosthetic devices and components in the world. Unfortunately, it has also had problems with some of its products which have led to recall. The company has issued voluntary recalls in 2008, 2010, 2014, and now with Zimmer tibial plate failure, 2015.

In 2008, there was a temporary recall of the Durom Cup hip component. In 2010, close to 70,000 Minimally Invasive Solution (MIS) Tibial Components were recalled.

In 2014, Zimmer recalled 40,000 units of one of its most popular products, the NexGen knee.  Finally, in February 2015, the company sent out an urgent voluntary recall of the Zimmer Personal Trabecular Metal Tibial Plate knee replacement system.

FDA Follows Up on Zimmer Recall

The Zimmer tibial plate failure recall was followed up with a formalized Class II recall announced by the Food and Drug Administration (FDA) in March 2015. The FDA concluded that the Zimmer tibial plate failure warranted Class II recall classification after careful review of the data.

This classification is for temporary or reversible health consequences that can be medically treated, but not necessary without significant risk to the patient. Several patients had experienced complications with this component of a total knee joint replacement unit which has two pegs that are intended to grow into the tibia (main lower leg bone) rather than be cemented.

X-Ray Revelations

Several complaints were issued by recipients of the Zimmer Persona Knee Implant because of post-surgical complications indicating the component was failing early on.

X-rays revealed gaps between the plate that sits on top of the lower leg bone, known as the tibia. These gaps indicated that there had been movement from the original surgical positioning of the piece.

Gaps between the tibial plate and the bone are known as radiolucent lines. In addition to heralding a general loosing and early failure of the plate, the gaps can allow for fluid build-up, accumulation of wear debris from the joint unit itself which can lead to infection and general pain, swelling, bone, and tissue damage.

Remedies for Radiolucent Lines

Radiolucent lines are indicators that knee revision surgery will be needed.  Knee revision is a common follow-up procedure that is typically scheduled 7-10 years after an initial joint replacement surgery.

A revision surgery generally allows for replacement of less durable parts of knee unit. But often with an indicator of possible failure present, a whole new prosthetic joint must be surgically implanted.

Who the 2015 Recall Affects

The 2015 recall of the Zimmer Persona Knee Implant affects 11,658 units that were sold and distributed.  Of those nearly 12,000 units sold, an unidentified percentage were installed and the recipients may have experienced loosening. In those cases, having the unit removed and replaced is entirely voluntary.

Are You Suffering Because of a Failing Zimmer Persona Knee Implant?

Patients may need to check in with their care provider if they have had a Zimmer Persona Knee Implant surgically placed but are experiencing any symptoms of joint pain, instability, inflammation, or loss of mobility.Those who believe they may have suffered as a result of a failed tibial plate may benefit from a consultation with a legal expert.