Questions?
(888) 391-1315

Canada's FDA Issues Recall of Stryker Hip Implants

Last week, DrugNews reported on a warning issued by Stryker Orthopedics for its LFit V40 femoral head used on several models of its hip replacement implants. Although the warning was sent only to doctors, experts believe the safety risks could result in a worldwide recall.

Now, Canada’s top health authority has issued a formal recall of these hip implant components, citing a higher-than-normal number of patient injuries.

In August, Stryker alerted doctors of problems with their LFit femoral heads through a Product Field Action Notification. Specifically, the company warned that the hip implant head attachments may experience taper lock failure, which can cause them to become separated from the lower stem part of the implant.

 

Latest Stryker Hip Recall

On September 21st, Health Canada last issued a recall alert addressing the same problems with these hip parts. They included the LFit COCR V40 femoral head and stated that Stryker "has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011."

 

Which Hips Are Affected?

The defective femoral heads are used with a variety of different stem systems. According to the alert, there is a risk of device failure with the following hip implants:

  • LFit V40 femoral heads between 36mm and 44mm
  • Accolade TMZF implants
  • Accolade 2 implants
  • Meridian implants
  • Citation implants

The potential taper lock failure of these defective hips poses several health risks for patients, including device separation, bone fractures, bone necrosis and poisoning from foreign metallic debris released in the bloodstream.

 

$1.4 Billion Paid So Far for Stryker Lawsuits

This latest Stryker hip implant recall is at least the fourth issued by the company since 2009, and comes just as they are resolving issues from thousands of patients affected by the 2012 recall of their Rejuvenate and ABG II hips.

In 2014, Stryker paid $1.4 billion to settle over 4,500 lawsuits filed by patients with the Rejuvenate or ABG II hip implants. Experts believe that a similar number of people could be affected by this latest recall.

If you or a family member received a Stryker metal hip implant, it is important to learn about your legal rights before agreeing to any recall terms. Contact us today for more information or to speak with a lawyer at no cost.

 

Sources:

Stryker. Product Field Action Notification. (August 29, 2016). Retrieved from http://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/8312-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1

Health Canada. Recalls & Alerts. LFIT COCR V40 and COCR LFIT Femoral Heads. (August 24, 2016). Retrieved from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60268r-eng.php

 

PREVIOUS ARTICLE
Next article

Continue reading

Other drugs and devices in the news.