The Stryker V40 recall affects thousands of metal on metal hip implants manufactured by the Stryker company.

The Stryker V40 recall was initiated voluntarily after Stryker reportedly received numerous injury reports alleging serious metal hip implant complications.

The Stryker V40 recall affects Stryker V40 femoral heads composed of cobalt and chromium metals, with potential problems reported in the “Urgent Medical Device Recall Notification” letter to surgeons on Aug. 29, 2016.

Stryker V40 femoral heads manufactured before 2011 and used in conjunction with the Accolade TMZF stem were considered highest risk for device failure. Similar to the V40 heads, TMZF stems were composed of strong metals that were marketed to last longer and be more durable compared to competing products.

Overview of Stryker V40 Recall

The Stryker V40 femoral heads and TMZF stems were supposed to provide patients with complete mobility, and replenish all limited movement caused by damaged or deteriorated hip bones.

In addition to marketing the Stryker V40 devices as superior, the company also advertised the medical devices as low risk in terms of dislocation. However, the company eventually initiated the Stryker V40 recall after receiving numerous injury reports indicating device failure including:

• The femoral head becomes disassociated from hip stem
• The hip stem fractures
• Metallosis (blood metal poisoning)
• Limited range of motion
• Soft tissue damage
• Infection
• Fretting
• Corrosion
• Device wear

Stryker V40 femoral heads were linked to increased risk of metallosis, or blood metal poisoning, with diagnostic tests finding metal ions in the damaged surrounding tissue. When the all metal ball and socket joints interact, metal ions may shed into the bloodstream and can develop into a number of different complications.

When these metal ions come into contact with tissue, the tissue can have adverse reactions like inflammation or fluid retention. This eventually causes the tissue to die, which allows the metal debris to enter the bones and bloodstream.

The Stryker V40 recall is not the first of its kind for the company, as Stryker has had to conduct a previous market recall of its Rejuvenate and ABG II metal hip implants in 2012. Similar to the Stryker V40 recall, the Rejuvenate and ABG II metal hip implants were withdrawn due to numerous reports of metallosis, joint infections, and device failure.

Patients who undergo hip implant surgery are seeking to restore their mobility and active life, which were compromised due to damaged hip joints. Metal on metal hip implants were marketed to be overtly superior to ceramic and plastic models, with manufacturers claiming they were more durable and longer lasting.

The all metal ball and socket joints, however, have allegedly caused more harm than good for many patients, with many having to undergo revision surgery. In July 2012, a study published in the medical journal Orthopedics had found that 95% of patients needed to undergo revision surgery within just three years after initial implant surgery due to metal hip implant complications.

Revision surgery is often the only option patients have to resolve metal hip implant complications, and is considered riskier than the initial implant procedure.