The Zimmer Persona knee replacement system has not been without its problems, as its use has been linked to a number of health issues and complications, including, but not limited to, post-surgical bone fractures and blood vessel and nerve damage. If you, or a loved one, have been harmed by this medical device the pharmaceutical attorneys at Baron & Budd may be able to help. To learn more, complete our online contact form or call us, toll free, at (866) 347-7765.
Understanding How the Zimmer Persona Knee Replacement System Works
The Zimmer Persona is one of many knee replacement devices for those who suffer from chronic pain conditions, like rheumatoid arthritis and osteoarthritis.
Manufactured by Zimmer Holdings Inc. the device was first approved for use by the FDA in 2012. It is made up of several different components and was marketed as the knee replacement system that most closely mimicked the natural knee joint, making it, for a time, a popular choice among hospitals and orthopedic surgeons.
Problems and Complications Associated with the Zimmer Persona Knee Replacement System
There have been, since its launch, a number of patient complaints and reports about serious side effects encountered after the placement of a Zimmer Persona knee replacement device, including:
- Persistent pain
- Persistent swelling
- Damage to nerve tissues
- Damage to blood vessels
- Implant failure
- Loss of range of motion
In some cases, when the patient complained of device failure, x-rays have been able to confirm their suspicions. Often it is a particular component of the system as a whole – the Persona Trabecular Tibial Plate – that has been found to be the problem. It loosens, opening up a gap between the natural bone and the implant, leading to instability and opening the way for post-surgical complications. Some patients have been left with secondary disease, including osteolysis (bone fracturing), and some have required revisionary surgery to remove the device to prevent further damage.
The FDA Recall of the Zimmer Persona Knee Replacement
In March 2015, after the receipt of numerous complaints and negative reports, the Food and Drug Administration (FDA) issued a Class II recall covering more than 11,000 Persona Trabecular Tibial Plate devices. Prior to the recall, Zimmer themselves sent a memo to hospitals requesting the removal of any unused devices from their inventory.
The recall was classified as a Class II, as it is considered that any damage caused by the use of the Persona Trabecular Tibial Plate is reversible, via a second surgery to replace it.
The 501K Problem
Many people wonder why a device that was found to not be fit for purpose was ever approved in the first place, and the short answer is that it was approved under a program known as 501K.
The 501K program allows medical device manufacturers to ‘fast track’ the approval of a new device if they can show that it is ‘not substantially different’ from other products already approved for use. In the case of the Zimmer Persona Knee Replacement, it was claimed that it was not unlike another Zimmer knee replacement device, the NextGen, and this was enough to gain it a speedier than usual FDA approval.
Zimmer Persona Knee Replacement Lawsuits
As previously mentioned, the FDA considers that any damage done by the use of the Zimmer Persona Knee Replacement to be reversible. This does not, however, relieve the Zimmer Company of their responsibilities towards affected patients.
Understanding this, it is not uncommon for the manufacturers of any faulty medical device to reach out to affected individuals in an attempt to secure a settlement and prevent expensive (for the company) litigation and additional adverse publicity. Should a patient accept such a settlement, they are required to sign an agreement that bars them from ever taking legal action on the matter, even if the condition caused by the device worsens.
As these settlements rarely reflect what a patient is truly entitled to, it is important that anyone considering signing such an agreement consult with an experienced attorney first. If you, or a loved one, have suffered as a result of the Zimmer Persona Knee Replacement System, Baron & Budd may be able to help. To discuss your case, and possible legal recourses, we offer a free, confidential consultation with one of our experienced attorneys. To schedule an appointment, or to learn more, simply complete our online contact form or call us toll free at (866) 347-7765.