The recent Stryker hip recall affects certain metal hip implants containing Stryker LFIT V40 Femoral heads due to a high number of injury reports.

The Stryker hip recall was initiated in August 2016, after the company discovered a higher number of revision rates discovered than it had previously expected. These injury reports indicated patients could experience “spontaneous disassociation” of the femoral head components, along with the development of metallosis and need for revision surgery.

Metallosis is a condition that occurs when metal ions are shed into the blood, from the interaction of the ball and socket components of the device. This often leads to infection, corrosion, and device failure, which ultimately forces patients to undergo revision surgery to resolve the problems.

This is not the first Stryker hip recall, as the ABG II and Rejuvenate metal on metal hip implants were also recalled from the market in 2012. These injury reports also indicated device failure, metallosis, and need for revision surgery.

A study was published on these metal hip implant complications in July 2012 issue of Orthopedics, which found that 95% of patients had to undergo revision surgery within three years of receiving the implant.

Overview of Stryker Hip Recall

After witnessing similar behavior in the Stryker LFIT V40 models, the company recalled those units from the market to prevent future patients from experiencing even more complications.

However, at the time of the recall, there were no Stryker LFIT V40 hip implants left to remove from provider’s inventories, because the remaining products had either expired or had already been implanted. The 2016 Stryker hip recall affects Stryker LFIT V40 hip implants manufactured between 2001 through 2011.

The Stryker hip recall affects approximately 44,000 units worldwide, as the Stryker LFIT V40 femoral heads are used in a number of Stryker’s hip replacement products. The Stryker LFIT V40 femoral head is the ball component composed of cobalt and chromium, and is primarily marketed with the TMZF titanium alloy stem that simulates the femur.

When combined, these components are supposed to replace damaged or deteriorated hip bones in hopes of restoring hip function. Stryker had marketed these metal hip implant components as providing a low risk of dislocation. In addition, Stryker’s marketing materials stated their alloys were stronger and more durable than other titanium alloys on the market.

The Stryker hip recall was initiated voluntarily by the company, after discovering they may have underestimated the likelihood of injury and need for revision surgery. Metal hip implant complications indicated in the injury reports include:

• Disassociation of femoral head from the hip stem
• Fractured hip stem
• Metallosis (Blood Metal Poisoning)
• Soft Tissue Damage
• Tissue Death of surrounding Hip Implant Site
• Excessive Wear
• Fretting
• Corrosion
• Debilitating Pain
• Device Failure
• Device Loosening

Even though the Stryker hip recall prevents future incidents, it does not help patients who already sustained injuries. These patients may be able to file legal action and should contact a lawyer to determine eligibility.