The Zimmer Persona recall of the company’s Persona trabecular metal tibial plate was conducted after a high number of injury reports were submitted which spurred the company to take action.

The Zimmer Persona recall was initiated in February 2015, with the FDA announcing the recall shortly after. The FDA gave the Zimmer Persona recall a Class II designation, which is reserved for medical products shown to cause reversible or temporary harm to patients.

The Zimmer Persona recall was initiated due to numerous patients and physicians reporting two kinds of complications with the Persona trabecular metal tibial plate, with many patients forced to undergo revision surgery.

The major issues reported included:

• Radiolucent lines: Lines or gaps between the knee replacement system and bone, which can be seen on X-ray images. Radiolucent lines are early signs of device loosening.
• Device loosening: Occurs when the trabecular metal plate moves out of its initial implant position. Zimmer says device loosening is “one of the most prevalent causes for revision in total knee arthroplasty.”

The Zimmer Persona recall impacted nearly 12,000 trabecular metal tibial plates, and many patients did not learn of the problems long until long after their implant surgery. According to Zimmer, 38% of patients suffered radiolucent lines forcing them to undergo revision surgery.

Overview of Zimmer Persona Knee Replacement Problems

The Zimmer Persona knee replacement system is often prescribed for patients who suffered knee damage from traumatic injury or degenerative disease, with the company marketing the product as a suitable choice for these patients.

The Zimmer Persona trabecular metal tibial plate is unique in its mechanism because it does not utilize cement. Instead, it uses two metal pegs that are inserted into the bone for stabilization. This feature of the design is meant to encourage natural bone growth and knee movement.

Surgeons directly implant the trabecular metal tibial plate at the top of the tibia without using cement or other adhesion. Zimmer promises that the trabecular metal tibial plate is reliable for knee stabilization.

However, numerous patients have reported serious complications soon after having the Zimmer Persona knee replacement system, with many of them forced to undergo revision.

According to the injury reports submitted, complications mentioned by patients include:

• Knee swelling
• Tightness of the knee joint
• Chronic debilitating pain
• Fracture
• Knee instability
• Limited mobility
• Device component loosening
• Lack of ingrowth
• Loss of fixation
• Instability
• Patella tracking problems
• Inflammation

These knee replacement complications stem from early device failure and need for revision surgery. However, patients have to be wary of post surgical complications after revision surgery, which is considered higher risk than the initial knee implant surgery.

Post surgical complications associated with revision surgery include:

• Pain and swelling
• Infection
• Nerve, tissue, or blood vessel damage
• Blood clots
• Bone loss
• Fractures
• Differences in leg lengths

Class action lawyers are currently investigating injury claims from patients who were forced to undergo revision surgery allegedly due to the defective nature of the Zimmer Persona TM tibial plate. Patients who had a Zimmer Persona knee replacement system implanted between 2012 to 2015 and suffered complications may be eligible for compensation.