Zimmer Biomet has issued a voluntary Zimmer tibial plate recall over loosening and injury associated with the device. The FDA has classified this as a Class II recall.

Zimmer Persona Implant Basics

People undergo knee replacement for a variety of reasons, due to conditions like rheumatoid arthritis, collagen disorders, inability to straighten the knee, and many more.

Zimmer, a major medical device company based out of northern Indiana, is the manufacturer of the Zimmer Persona implant, which uses a tibial plate implanted directly into the tibia without using cement. There are two pegs that are implanted into the bone that are supposed to “grow” into place over time, stabilizing the implant for long-term use.

Despite the undeniable popularity of the Zimmer Persona device, the knee implant has also been linked with some serious complications. As result, the FDA issued a Zimmer tibial plate recall in March 2015, affecting around 12,000 implants altogether.

Zimmer Tibial Plate Recall

The Zimmer tibial plate recall came after the FDA became aware of reports of the device loosening from its proper position, as well as X-rays which showed that there was a gap between the device and the patient’s bone.

The Class 2 recall (issued for devices that are capable of causing temporary or reversible harm) notes that all sizes of the Zimmer Persona tibial plate component may be able to cause problems, and were affected by the Zimmer tibial plate recall.

Zimmer Persona tibial plate failure has led to several recognizable symptoms, including:

• Persistent pain
• Loss of mobility
• Inflammation
• Knee instability
• Knee tightness

The two major complaints that come up most often with this device are radiolucent lines, or gaps between the knee implant and the bone, and loosening of the device.

Indeed, according to Zimmer, around 38 percent of patients who sent complaints about the Zimmer Persona tibial plate either had these radiolucent lines or had to undergo revision surgery due to failure of the knee implant.

Patients cite several reasons for needing to undergo Zimmer Persona knee revision surgery including device loosening, fracture, instability, and persistent pain. However, any revision surgery exposes a patient to further serious risk, including infection, fractures, blood clots, bone loss, device failure, damage to nerves, tissue, or blood vessels, as well as substantial medical costs.

If you or someone you love has been harmed due to issues with a device affected by the Zimmer tibial plate recall, you may be able to file a Zimmer lawsuit. While filing a lawsuit cannot undo the physical pain and emotional suffering caused by problems with the knee implant, it can help to compensate for medical expenses, lost wages, and other costs associated with these injuries.