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:
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.
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
Cerebral Palsy is the most common form of childhood disability in America, affecting nearly 1 out of every 500 births and as many as a million young people at any given time.
Since news broke last year that medical device maker DePuy Orthopedics may have instituted a secret DePuy Attune knee recall, the company has been trying to combat a series of negative reports and hundreds of consumer lawsuits by those needing revision surgery.