Zimmer NexGen Knee Recall

Several components of the Zimmer NexGen Knee Replacement system have been subject to FDA recall after numerous patients experienced serious complications. Zimmer NexGen Knee recalls have included, NexGen Tibial Trays, MIS Tibial Components, MIS Modular Tibial Plates and Keels, and NexGen LPS-Flex GSF Femoral components.

Quick Summary
Zimmer NexGen Knee Recall

The Zimmer NexGen Knee replacement system has been used in hundreds of thousands of people but some of the components have caused serious complications for many who received them. Zimmer Biomet was forced to issue several recalls for NexGen components between 2010 and 2014.

Zimmer NexGen Knee components which have been subject to recall have included:

  • NexGen TM Tibial Trays
  • NexGen MIS Tibial Components
  • NexGen MIS Modular Tibial Plates and Keels
  • NexGen LPS-Flex GSF Femoral Component

The recalls were issued after multiple reports had indicated patients were experiencing severe pain, device loosening and subject to knee revision surgery at a higher than expected rate. Component recalls may have affected upwards of 100,000 implanted devices over a 4 year period.

Zimmer NexGen Knee Complications

Zimmer NexGen Knee system was intended to be more durable and closely mimic natural movement for a younger and more active patient. While hundreds of thousands of patients may have had successful knee replacement with the NexGen system, some components have proven to be troublesome and have resulted in complications such as:

  • Device loosening
  • Joint dislocation
  • Loss of mobility
  • Bone loss
  • Infection
  • Revision surgery

Patients who suffer device failure may be required to undergo multiple surgeries to remove and replace the faulty device and reconstruct damaged tissue.

Zimmer NexGen Knee Recall

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 as a whole, recalls have been issued for separate components used in the NexGen implants. Multiple Zimmer NexGen knee recalls were issued for separate components between 2010 and 2014.

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

Overall, the system has been subject to a higher-than expected complication rate. 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.

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 which are assembled after insertion rather than before.

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.

 A similar recall was required to be issued for the same component in 2014, affecting in total, up to 100,000 devices.

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.

Other Zimmer Knee Recalls

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 has also been forced to recall parts of the newer Zimmer Persona Knee system, including a 2015 recall of the Trabecular Metal Tibial Plate which caused complications after the device loosened in patients who were then required to undergo revision surgery.

Zimmer NexGen Knee Side Effects

While all knee replacement systems cause a number of side effects such as bruising, swelling and pain, most of these symptoms will go away after recovery from the surgery. Side effects or complications which worsen, occur suddenly or are unexpected may indicate problems with the device.

Side effects which have been attributed to NexGen failure include:

  • Device loosening
  • Joint dislocation
  • Loss of mobility
  • Bone loss
  • Infection

When device loosening, joint dislocation or other complications develop, the patient will often be required to undergo revision surgery to remove and replace the defective device and repair damaged tissue. Each additional surgery will require additional recovery time and pose more risk to the patient.

Zimmer NexGen Knee Lawsuits

Up to 100,000 Zimmer NexGen Knee components may have been implanted in patients who later experienced complications. Many oif these victims have filed lawsuits against Zimmer Biomet for injuries caused by the NexGen Knee replacement devices. Some federal lawsuits were consolidated into multidistrict litigation and while some have settled, others may have been placed on hold and have yet to be resolved.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.