Stryker Orthopaedics Voluntarily Recalls its Rejuvenate and ABG II Modular-Neck Stems

On July 10, 2012, Stryker Orthopaedics recalled its Rejuvenate hip system and ABG II modular-neck stems, both of which are popular components of many of its most popular hip implant systems. Both the Rejuvenate and ABG II modular-neck stems may be used with either metal or ceramic hip implants. However, the Stryker components themselves are composed of metal-on-metal conjunctions. Much like the complications linked to other Metal-on-metal implants such as the beleaguered Depuy ASR hip implant, friction between the moving parts in the Stryker components may cause toxic metal debris to gradually accumulate in the blood stream. Common complications include extreme pain, swelling, nausea, permanent tissue damage and metallosis.

The Stryker Rejuvenate hip system and the ABG II modular-neck stems are components that may be categorized as metal-on-metal joint replacement systems. In recent years, metal-on-metal systems have been heavily scrutinized for their high failure rates. The National Joint Registry of England and Wales found that roughly 6.2% of all metal-on-metal hip replacement systems required revision surgery within 5 years, compared to only 1.7% for metal-on-plastic systems and 2.3% for ceramic-on-ceramic systems. Stryker initially marketed its Rejuvenate hip implant system as providing a complication- free 15-year clinical history. However, since the beginning of 2012, the FDA has received over 45 adverse event reports in relation to complications associated with Stryker’s Rejuvenate and ABG II modular-neck stems. The side effects most commonly cited in the adverse event reports are fretting, wear or damage between caused by repeated surface friction, and corrosion.

In a recent press release, Stryker focused on the complications associated with potential fretting and corrosion and the potential risks and benefits for systems with the component parts in question. Stuart Simpson, Vice President and General Manager of Hip Reconstruction stated,” While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action”. Smith goes on to state,” Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data.”

Styker has issued a global recall for both component parts and is urging patients with hip implant systems with either of these products to contact their surgeons as soon as possible to confirm that no fretting, corrosion, or other serious complications are present.

Symptoms:

• Inflammation/Swelling
• Intense paint at the site of hip replacement
• Groin or thigh pain
• Metallosis
• Spontaneous Dislocation
• Tissue Mass or Rash
• Black tissue
• Bone Deterioration
• Chromosomal Damage
• Carcinogenesis (development of cancerous cells)
• Increased Lymphocytes (Lymphocytosis- results in “sick” symptoms)
• Necessity for additional surgeries to remove implants, mass tissue buildup, or infected bones.

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