Reports of hip implant failures, damage and postsurgical complications have led to another Stryker hip replacement recall.

Stryker, a manufacturer of several different artificial hips, has issued a voluntary recall of certain sizes of its LFIT V40 femoral head.

The device has been associated with reports of failure, requiring patients to undergo revision surgery to repair damage and replace the implants.

The LFIT V40 is a component of the company’s Accolade TMZF and Accolade 2 hip implants and in its Citation and Meridian stems.

This latest Stryker hip replacement recall affects seven different sizes of the LFIT V40, with head diameters ranging from 36 to 44 millimeters.

Reasons Behind the Stryker Hip Replacement Recall

The Stryker hip replacement recall was spurred by reports of complications associated with metallosis, a toxic reaction to metal let loose inside the body.

As with some other hip implants that have metal-on-metal bearing surfaces, the LFIT V40 can reportedly shed particles of cobalt and chromium metal into the surrounding tissue – a phenomenon known as fretting.

The loose metal particles can build up to a toxic level, causing metallosis. This condition can lead to the death of the surrounding tissue, including the bone directly adjacent to the implant.

The LFIT V40 has also been implicated in reports of implants that spontaneously dislocated or dissociated.

Other reported problems that led to the Stryker hip replacement recall include poor range of motion, noisiness, and loss of the implant’s fixation strength within the bone.

Other Stryker Recalls

Stryker’s current recall of the LFIT V40 femoral head is voluntary and not mandated by the FDA.

Health Canada, however, issued a recall in August 2016 for specific lots of certain sizes of LFIT V40 femoral heads manufactured prior to 2011.

The Canadian regulatory agency said that Stryker has received more than the expected number of complaints of failure of the device’s taper lock.

Health Canada had previously issued another recall of the LFIT V40 femoral head in September 2015, citing reports that femoral heads manufactured from July 2014 to August 2014 could not be assembled with the accompanying stem.

The company’s Rejuvenate and ABG II hip stems were also subject to recalls in 2012. These stems had been manufactured from a proprietary titanium-based alloy that Stryker said was designed to resist corrosion and fretting.

But post-market information revealed reports of corrosion and fretting associated with these devices.

The FDA had received over 60 reports of metal toxicity severe enough to require revision surgery. Some patients also reported the implants had come loose after implantation.

Revision surgery comes with its own set of complications. Removing an implant requires detaching its anchor from deep within the femur, creating a risk that the femur may fracture.

Some patients have had to undergo more than one revision surgery, exposing them to even more risks of complications.

These reported problems with the ABG II and Rejuvenate stems led to a wave of products liability litigation.

Plaintiffs alleged Stryker failed to properly test these devices before allowing them to be used. They accused the company of failing to warn doctors and patients about the potential risks associated with these devices.

While some of these claims were settled for undisclosed amounts, Stryker projected the litigation could cost the company as much as $1.3 billion.