Zimmer was first founded in 1927 with the manufacturing of aluminum splints. The company has grown to produce a variety of orthopedic products, such as surgical products, artificial joints, spinal devices, and trauma devices. Zimmer plays a large role in the world’s knee replacement market with an estimated 26 percent market share. It is estimated that Zimmer earns more than $7 billion in sales worldwide.
In 1995, Zimmer released the NexGen Complete Knee Solution System. This system was successful for a number of patients. Building from this success, Zimmer altered the design to create a new line called the NexGen Flex. The Zimmer NexGen Flex system was designed to provide patients with a greater range of motion that other knee replacements could not offer. The NexGen system boasted 155 degrees of knee flexion. The industry standard is 120 degrees. Flexion is the ability of the knee to bend.
Many patients experienced severe side effects from the NexGen system. While the NexGen system has never been recalled, recalls have been issued for separate components used in the NexGen implants. Two Zimmer NexGen knee recalls occurred in late 2010.
The Zimmer NexGen knee recall components included:
- NexGen TM Tibial Trays
- NexGen MIS Tibial Components
- NexGen MIS Modular Tibial Plates and Keels
- NexGen LPS-Flex GSF Femoral Component
In 2012, a Zimmer knee recall occurred that was not part of the NexGen line. This Class II recall was for the Natural-Knee II Durasul Patella. The product was allegedly prone to fracture. As a result, many patients experienced patellar problems and device failure.
Zimmer NexGen MIS Tibial Components
The Zimmer NexGen MIS Tibial Components were designed for use within the NexGen LPS-Flex and NexGen CR-Flex knee implant systems. Minimally invasive procedures use the tibial components. During these procedures, orthopedic surgeons perform the knee replacement operation through an incision measuring 4 or 5 inches. In a traditional knee replacement surgery, the incision measures between 8 and 12 inches. This minimally invasive process aims to minimize patient recover time and blood loss.
However, this procedure can also prove to be more difficult and prone to error. There were a number of reports for high failure rates associated with the MIS Tibial Components. In response to these reports, Zimmer issued a letter in April 2010. This “Urgent Field Safety Notice” and “Urgent Device Correction” letter discussing the challenging nature of the implants and subsequent alignment and fixation issues. During the same year, the components were recalled.
NexGen LPS-Flex GSF Femoral Component
The NexGen LPS-Flex GSF Femoral Component was also part of the series of Zimmer NexGen knee recalls. This component was created and marketed for use in female knee replacement patients. Zimmer intended for the component to provide increased stability and superior fit to female patients.
However, the component was associated with a tendency to loosen. The FDA reported that the component may collapse. In order to fix a collapsed component, the patient must undergo revision surgery. This Zimmer NexGen knee recall took place due to “nonconforming geometry.” Once implanted, the implant parts failed to fit together properly.
Zimmer NexGen Knee Recall Requests
There are a number of requests encouraging the FDA to issue a Zimmer NexGen knee recall. These requests are based on high reports of failure and the need for patients to undergo revision surgery to correct the knee implants and issues caused by the knee implants.
In 2010, a former consultant for Zimmer distributed data from a two-year review of more than 100 patients who received the Zimmer NexGen CR-Flex Porous implant. The results revealed that roughly 9 percent of patients required revision surgery within the first two years of receiving the implant. Additionally, 36 percent of patients showed signs of implant loosening.