ALERT: Your health is top priority. We’re committed to providing reliable COVID-19 resources to keep you informed and safe.

Zimmer Recalls 40,000 NexGen Knee Models

Threads of Zimmer Knee Component

Zimmer Manufacturing initiated another sweeping recall on one of its artificial knee implants, the NexGen MIS Tibial Component, this time because one of the pieces could loosen or fail because of shoddy manufacturing.

Zimmer said the threads on the NexGen Complete Knee Solution Tibial Component might be “out of specification” in more than 40,000 devices. In its letter to medical professionals, Zimmer said some of the tibial baseplates were made with defective threads in a hole where surgeons screw in a drop-down stem extension or stem plug. If not threaded correctly, the device could loosen and fail.

Zimmer said the problematic device could lead to one or more post-surgery complications:

  • Infection: The patient runs the risk of serious infection if the surgery is delayed or if a secondary implant is not immediately available and the surgeon must close the patient and return later.
  • Bone Loss: The patient may have additional bone loss if the tibial device is cemented in place and the surgeon must remove and replace it.
  • Early Revision Surgery: If the device loosens or infection occurs, this could lead to revision surgery.
  • Dislocation: If the stem is not properly placed, the devices may not adequately lock. This could lead to a dislocation.

The voluntary recall affects 41,180 devices and includes eight sizes (1-8).

Faulty Knees Distributed from 2010-14

Zimmer initiated the recall after it received 12 complaints in a 2 ½-year period. The faulty devices were distributed during a four year period between February, 2010 and May 2014. The recall started May 19.

The recall is considered a class 2 recall, indicating the damaged device might cause temporary or serious medical complications. Zimmer sent out the urgent medical device recall letter to medical professionals on June 10. Devices were manufactured at the company’s plant in Ponce, Puerto Rico.

The knee – formally called the Zimmer NexGen Complete Knee Solution MIS (Minimally Invasive Solution) Total Knee Procedure Stemmed Tibial Component Fixed-Bearing Precoat – is commonly used with other Zimmer knee replacement systems like the LPS-Flex and CR-Flex minimally invasive knee replacement devices. Doctors install the tibial component during minimally invasive knee surgery, which has shorter recovery times, less blood loss and a greater range of motion because of tissue-sparing techniques. They assemble the component once the new knee is put in place. That tends to make the faulty pieces more problematic.

Previous Knee Recall Led to Lawsuits

This isn’t the first time the MIS Tibial Component has come under fire. In April 2010, Zimmer found that loosening could occur if the tibial component is not fully cemented or the drop-down stem extension isn’t used.

Within months of the company’s urgent device correction letter, the U.S. Food and Drug Administration (FDA) received 114 complaints of early loosening and found that the company provided improper instructions and warnings about the device to surgeons. The FDA issued a class 2 recall, affecting 68,383 devices that had already been implanted.

Shortly after the FDA issued its recall, injured patients started filing lawsuits. A multidistrict litigation (MDL) was opened in the U.S. District Court of Illinois under the oversight of Judge Rebecca Pallmeyer.

Today, there are more than 1,000 lawsuits. The initial trial date is set for February 2015.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine

3 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. Australian Government. (2014, July 9.) NexGen Complete Knee Solution MIS stemmed tibial component (various sizes). Department of Health: Therapeutic Goods Administratino. Retrieved from
  2. U.S. Food and Drug Administration. (2014, June 27). Class 2 Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat. Retrieved from
  3. FDA. (2014, July 9.) Enforcement Report. Retrieved from
View All Sources
Who Am I Calling?

Calling this number connects you with one of Drugwatch's trusted legal partners. A law firm representative will review your case for free.

Drugwatch's trusted legal partners support the organization’s mission to keep people safe from dangerous drugs and medical devices. For more information, visit our partners page.

(888) 645-1617