The Zimmer Persona knee replacement, like many joint replacements, is intended for use in patients that are suffering from frequent pain and loss of mobility in the affected area. In the vast majority of cases, joint replacement surgeries are for patients over 50 years of age, as this is when arthritis becomes more common. However, the Persona is different, as it was designed for use in younger patients. These are patients that have injured their knees in sports or other activities, and the device is meant to mimic the action of younger, more active joints. Unfortunately, the unique design hasn’t made it immune to many of the same problems that other joint replacements have, and these complications can leave a patient in terrible shape.
An Industry-Wide Recall
In March 2015, Zimmer instituted a voluntary recall for all of its Persona knee replacement devices. In response, the FDA instituted its own Class II recall for the knee replacement components, a recall believed to have affected 11,658 devices. A Class II recall means the device or drug in question may cause temporary adverse health consequences if a patient is exposed for a period of time. However, some experts believe this underestimates the impact that a faulty Persona knee replacement can have on a patient.
According to the company, the recall was done in response to reports of radiolucent lines and component loosening. The component loosening is easy to understand, as medical devices can and do frequently loosen following installation. This can cause components to drift and contact other tissues in the body. A situation that can result in serious pain and tearing.
The radiolucent lines, an obscure medical term, is much more unsettling. Technically, it refers to areas on X-rays that are visible. When used in this context, it means that doctors are noticing, through X-rays, that spaces are building up and widening between parts of the implant. When a doctor notices radiolucent lines on imaging, it signals that serious underlying complications are likely developing. For example, fluid may seep into cracks in the implant, exerting more and more pressure until it snaps apart. Fluid and tissue buildup in the implant can also create pressure on surrounding bone, damaging it in a process known as osteolysis.
If unchecked, osteolysis can cause total bone failure and fractures, a complication that is well-known to doctors managing joint replacement cases. Even worse, when an implant fails, additional surgeries are required to remove or repair it, and this entails other risks, such as damage to nerves. While the FDA may classify such complications as temporary, some victims would likely take issue with that.
A History of Product Issues
About a month before Zimmer recalled its Persona knee replacement components, it sent an urgent notice to doctors, hospitals, and surgeons, telling them to immediately quarantine all Persona components. It’s a process that Zimmer is all too familiar with.
In recent years, many medical devices have been pulled from the market for failure rates, and as one of the largest device manufacturers in the world, Zimmer has been among the companies required to do so.
In 2008, Zimmer instituted a short recall for its Durom Cup hip replacements. Zimmer representatives claimed that the recall was necessary because surgeons performing the procedure were not trained well enough. However, several experts, including one of Zimmer’s own paid consultants, found that the implant’s circular edge made it nearly impossible to keep it in place.
In 2010, Zimmer was required to recall approximately 70,000 MIS Tibial devices, also due to early loosening. And in 2014, the company’s flagship product, the NexGen Knee replacement, couldn’t escape the pattern of recalls when more than 40,000 were removed due to defective screws.
There have been several waves of Zimmer knee lawsuits as a result of its defective implants, and they have partitioned $70 million alone for damages resulting from the Durom Cup. Similar funds have been allocated for NexGen and MIS failures, and other funds will likely be set aside due to Persona failures.
A knee replacement failure is a medical nightmare for victims, with pain and extensive tissue damage among the common complications. It can take years to recover from a joint replacement failure, and in some cases, complications may be permanent. It’s important, then, that victims consult with an attorney as soon as possible to explore their potential legal claim.