The Food and Drug Administration has ordered the recall of nearly 11,000 Profemur Varus/Valgus metal-on-metal hip implants.

This is a Class I medical device recall, which was announced on Oct. 2. The manufacturer has relayed this message to its distributors and associated hospitals, after a large number of injury reports were reported to them.

MicroPort Orthopedics Inc. made the metal hip implant that has been linked with complications, which eventually led to the recall.

A Class I recall indicates that the FDA believes that these products have a definite possibility of inducing serious harm or death to patients, making a Class I recall the most serious to a medical device recall.

Along with injuries, metal hip implant patients reported needing revision surgeries or had to have the devices removed due to complications such as metallosis, device faiure, infection, and fretting.

MicroPort first announced the news to distributors and hospitals on Aug. 7, affecting metal-on-metal hip implant model components: PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254.

These parts were manufactured from June 15, 2009 to July 22, 2015, and distributed from June 15, 2009 to July 31, 2015. This could affect 10,825 metal hip implants.

Allegedly, the majority of implant complications from these all metal hip implant models, comes from the ball-and-socket joint components that constantly interact with each other.

When these parts interact, metal ions are shed. This leads to blood-metal poisoning, and other long-term consequences.

Overview of Metal Hip Implant Complications

The recent Profemur recall has asked distributors and hospitals to review their notification, and make sure all medical staff and patients are warned. The company also wants distribution centers to find the hip implant parts and to cease the products’ distribution.

In August 2013, MicroPort had begun manufacturing the Profemur hip implant when the company bought Wright Medical Group’s OrthoRecon business.

However, even before the purchase, patients had complained of hip implant complications. Some even reported that the devices had actually fractured or broke, causing the patients to become completely immobile.

For patients who have already had the Profemur hip implant surgically implanted, MicroPort advises patients to check with their doctors immediately, especially if they experience any pain, difficulty walking, tingling or loss of feelings in their leg.

A large number of metal hip implant lawsuits have already been filed against MicroPort, for failing to warn patients against the dangers of their product. Most of these hip replacement lawsuits were settled by Wright Medical group in late 2013 to early 2014, but more are expected.