The Zimmer Persona Knee system, the newest approach to arthroplasty, is a semi-constrained knee prosthesis for patients who have severe knee pain and disability. Although the system is intended to be highly personalized – gender, age, bone type, and even ethnicity are taken into account to create the most suitable fit for each individual – reports of loose implants have come pouring in, nonetheless. Loose implants can cause swelling, pain, tissue and bone damage, and will most likely require revision surgery, which requires removal of the original device and replacement with a new device.
Warsaw, Indiana-based Zimmer, Inc. voluntary recalled the Persona Trabecular Metal Tibial Plate system, including all lots and sizes used for knee replacement procedures between November 2012 and early 2015, because of implant failure resulting from loosening. In a statement to hospitals, Zimmer said, “… out of the complaints received, 36 percent identified symptomatic radiolucent lines or were revised for loosening, 28 percent identified asymptomatic radiolucencies (large gaps in between the device and healthy bone), 8 percent subsided, and 28 percent were inconclusive. Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.”
In 2008, the Durom Cup hip component was recalled because surgeons were not adequately trained to correctly perform the procedure. Zimmer’s very popular NexGen and High Flex knee devices were improperly marketed towards a younger, more active demographic, resulting in failure and loosening of the devices. NexGen Knee models had 40,000 recalls due to defective screws, and MIS Tibial recalled 70,000 due to early loosening.
Many knee replacement devices on the market today, including the Zimmer Persona Knee, were cleared by the FDA under a “fast-track” procedure that allows manufacturers to bypass expensive – and apparently useful – clinical research. This is called the 510(k) Pre-market Authorization Program, and under this program, a new device may be cleared if it is similar to products that are already on the market.
Although the FDA has sent warnings requiring that all hospitals, surgeons, and surgical centers discontinue the implantation of these devices, such warnings are too late for the estimated 11,500 patients who are at a high risk for implant failure and side effects that make the need for revision surgery highly likely. Unfortunately, the surgery required to repair a failed Zimmer Persona Knee device is often more complicated than the original surgery, and with a more complicated surgery comes longer healing time and more painful recovery.
Patients who have undergone Zimmer Persona Knee surgery should understand the likelihood that their device may fail. And since this product has been recalled, it is possible that the manufacturer could contact patients to offer an early settlement in exchange for waiving of rights. It is extremely important that patients speak to an experienced attorney before talking to Zimmer representatives, as their ultimate goal is to free the company of future liability.
Patients who must undergo revision surgery, or who have suffered complications, may be eligible for a monetary settlement to help cover medical costs, lost wages (surgery and recovery time for the initial surgery, as well as the revision surgery), pain and suffering, and any other damages that have been caused by the Zimmer Persona Knee. However, to ensure appropriate compensation when you’ve been injured, it’s important to seek the services of an attorney who is not affiliated with the manufacturer and who will work for your best interests.
To arrange a free evaluation of your case and explore your legal options, call Macaluso & Fafinski today at 718.364.4000 (in the Bronx) or 212.480.9000 (from elsewhere in New York), or simply fill out our convenient online form, and we will respond as soon as possible. The offices of Macaluso & Fafinski are conveniently located to serve the five-borough area and its residents.