Zimmer, an Indiana-based worldwide leader in musculoskeletal health care, recently issued a Class II Recall for the Zimmer Persona knee implant. The Persona was on the market for barely more than two years—from November 2013 through January 2015. The official recall was issued on March 12, 2015, however prior to that time Zimmer halted sales of the device, notifying physicians, distributors and hospitals of the impending recall in order to have Persona inventory returned to Zimmer.
The recall came on the heels of a large number of consumer complaints regarding the Persona. In particular, patients noted premature loosening of the knee implant. In fact, nearly six complaints for every one thousand implanted devices were received by Zimmer—an unusually high number. More than a third of those complaints involved radiolucent lines and the necessity of having the device removed and replaced with a safer alternative due to loosening of the device. According to the FDA, 11,658 Persona knee implants were affected by the recall. Like Zimmer’s NexGen knee implant, the Persona was designed for younger, more active patients, however Zimmer’s marketing claims for the Persona don’t seem to have stood the test of time.
ZIMMER’S HISTORY AND THE PERSONA KNEE IMPLANT
Zimmer currently employs more than 8,500 people, providing orthopedic devices to more than 100 countries. Justin O. Zimmer, with fellow salesman J.J. Ettinger, quit their jobs and founded the Zimmer Manufacturing Company in the basement of Zimmer’s home, in 1926. Zimmer’s vision resulted in the company quickly gaining market leadership during its first year of business. By 1987 Zimmer’s sales topped $500 million, and the company manufactured more than 7,000 orthopedic products. Today, Zimmer’s estimated annual revenues top $4.6 billion, with more than a third of that income based on knee implant devices.
ZIMMER PERSONA GAINS FDA APPROVAL UNDER CONTROVERSIAL 501(K) PROCESS
The Zimmer Persona, a porous coated, un-cemented device, gained FDA approval in 2012, under the controversial 501(k) application process. This type of FDA approval permits manufacturers to bring a new device to market without benefit of rigorous clinical testing. The device must only be shown to be “substantially similar” to another product on the market. Following FDA approval, the Persona knee implant was widely used in the treatment of severe knee pain or disability due to such health issues as: rheumatoid arthritis, osteoarthritis, post-traumatic loss of joint configuration, collagen disorders, avascular necrosis and failed prior surgical attempts to save the knee.
POTENTIAL RISKS ASSOCIATED WITH THE PERSONA KNEE IMPLANT
Many patients implanted with a Zimmer Persona knee device experienced one or more of the following:
• Severe inflammation in the knee;
• Loss of mobility;
• Moderate to severe chronic pain;
• Tightness in the knee area;
• Loosening of the Persona device;
• Instability of the knee, and
• Radiolucent lines.
THE SIGNIFICANCE OF RADIOLUCENT LINES
Radiolucent lines are dark lines seen in a radiological analysis, and generally appear either immediately or at around two years following initial implantation of the device. Radiolucent lines are more frequently seen in un-cemented devices such as the Zimmer Persona and typically represent a poor implant seat. These lines are also associated with early loosening of the knee implant as well as complete failure of the device. It is theorized that patient pain is a positive indicator of the presence of radiolucent lines.
PERSONA SIDE EFFECTS, MILD TO SEVERE
Most patients will experience only temporary side effects from the Persona such as bruising and swelling of the knee, stiffness and moderate levels of pain. Others will experience severe and increasing knee pain, nerve damage (which could be permanent), particle shedding from the Persona device which can lead to tissue damage and bone fractures around the implant.
ZIMMER PERSONA REVISION SURGERY
Unfortunately, revision surgeries for knee and hip implants are considered to be significantly more complex and invasive than the original surgery. Revision surgeries require longer times on the operating table, with the potential for excess blood loss and infection. The recovery period for revision surgery is also considerably longer than for the original surgery.
GETTING THE LEGAL HELP YOU NEED
The Zimmer Persona recall is fairly recent, therefore lawyers who are knowledgeable about the issues associated with the Persona expect lawsuits to be filed against Zimmer as more patients face failure of their knee implant. In some instances, when a recall for a medical device is issued, manufacturer’s representatives contact patients offering an early settlement in exchange for waiving their rights. It is crucial that any patient experiencing problems with their Zimmer Persona contact an experienced attorney prior to signing any forms or giving a statement to the manufacturer, representatives of the manufacturer or an insurance company.