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Spangenberg Shibley & Liber LLP | Sep 9, 2015

The FDA's Stance on the Zimmer Persona Trabecular Metal Tibial Plate

Categories: Defective Drugs and Medical Devices

After developing its first total knee replacement in 1968, Zimmer has since had several successful models. Zimmer began in 1927 in the state of Indiana, manufacturing aluminum splints. Today Zimmer is the world’s top producer of knee replacement implants with an estimated $7.2 billion in revenues directly related to knee replacement devices. In late June 2015, Zimmer merged with Biomet, making the company an even greater contender in the areas of artificial joints, surgical products and trauma and spinal devices. Unfortunately, along with its successes, the company has also had to deal with some artificial knee implant problems—some of them quite serious.

Recall of the Zimmer Persona Trabecular Metal Tibial Plate

In March 2015, the Zimmer Persona Trabecular Metal Tibial Plate was recalled, after less than three years on the market. The reason for the recall, according to Zimmer, was an increased risk of the implant loosening, as well as radiolucent lines. The Persona Trabecular Metal Tibial Plate is a cementless (in other blogs, cementless is one word) component. Recipients of the Zimmer Persona Trabecular Metal Tibial Plate may develop radiolucent lines, which are dark areas on x-rays, signifying spaces between the device and the bone tissue. The Trabecular Metal Tibial Plate is a component which fits over the shin bone, providing a “platform” for the rest of the knee implant. The radiolucent lines seen in an x-ray indicate poor “seating” of the plate, indicating it is not where is should be, and is coming loose.

How a Class II FDA Recall May Affect Recipients of the Persona

The FDA announced that all sizes and lots of the Persona Trabecular Metal Tibial Plates would be removed from distribution immediately at the time of the recall. There are more than 11,000 of the devices which have been sold; it is unknown how many of those have been implanted in consumers. The recall, according to the FDA, was a Class II Recall. A Class II Recall is issued when a device is found to cause temporary or medically reversible adverse consequences. In fact, the Persona Trabecular Metal Tibial Plate may cause more serious complications. When the device loosens, the patient may experience:

  • · Tightness in the knee area;
  • · Mobility problems;
  • · Instability of the knee;
  • · Infection;
  • · Pain and swelling;
  • · Nerve, tissue or blood vessel damage;
  • · Wearing away of the bone;
  • · Loss of bone and tissue;
  • · Fractures of the bone, and
  • · Complete failure of the implant.

Persona Approved by the FDA through “Fast-Track” Program

The Zimmer Persona Trabecular Metal Tibial Plate gained FDA approval through the controversial 510(k) fast-track program. When manufacturers apply for 510(k) approval, they are not required to conduct clinical trials which would (or would not) show the device is both effective and safe. Under the 510(k) program, the manufacturer must only show the device is “substantially similar” to a product which is already on the market. While the goal of this FDA process is to limit the “red tape” involved in getting much-needed medical devices on the market, it can sometimes lead to unsafe devices being implanted in patients.

Much Higher-than-Normal Number of Complaints Associated with the Persona

Zimmer reported receiving approximately six complaints per 1,000 implants—significantly more than the number of complaints for similar devices. More than a third of these complaints involved revision surgery due to the premature loosening or other issues associated with radiolucent lines. The Zimmer Persona Trabecular Metal Tibial Plates were distributed across the United States, including at least a dozen VA hospitals. These recalled Persona components were also sold in Europe, Australia and other countries. It is not clear whether patients implanted with a recalled Zimmer Persona knee device have been notified of the recall or provided instructions regarding the necessity for further medical monitoring. It is expected that individuals who suffered injury from a Zimmer Persona Trabecular Metal Tibial Plate may pursue a lawsuit against Zimmer . This reference to Biomet is confusing and not really needed.