Stryker Issues Warning On Total Ankle Replacements

Stryker Issues Warning On Total Ankle Replacements

Introduction

On October 11, Stryker issued a safety notice concerning its  STAR Total Ankle Replacements distributed before August 2014. The notice warns patients and doctors about the risks associated with ankle replacements, which could result in significant pain, loss of mobility, and require revision or replacement surgery.

Stryker Corporation of Kalamazoo, Michigan, manufactured the product and distributed it to hospitals and medical facilities across the nation. It is used to repair ankle joints that have been affected due to the development of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. The replacement helps to increase mobility and provide joint pain relief.

Currently, the U.S. Food and Drug Administration (FDA) has received more than 100 reported polyethylene fractures related to ankle replacement. According to a Post-Approval Study (PAS), there has been a 13.79% fracture rate in patients who got the replacements.

Stryker Orthopaedics is known for the development and manufacture of specialty surgical products and other medical supplies for health care around the world. The company has manufactured scores of medical devices and joint replacement products, most of which have been successful; however, some of the hip replacement devices have caused serious adverse events, injuring hundreds of patients.

The Stryker Rejuvenate Modular-Neck Stem and the ABG Modular-Neck Stem hip replacement devices were approved by the FDA in 2008 and 2009. These devices are not typical "metal-on-metal" (MoM) as the necks are built of Cobalt and Chromium and the neck stems are layered with Titanium. Though the intention was to make it corrosion resistant, the two metals rubbed on each other at the connection and released toxic metal ions and debris. Stryker permanently recalled the Rejuvenate Modular and ABG II Modular-Neck Hip Stems in 2012 and stopped all global sales and production of these components. Another hip stem model, the Accolade TMZF, also caused problems and was recalled in 2009, 2011, and 2013.

Stryker is also facing lawsuits over problems related to its hip replacement products, including the Stryker Rejuvenate and ABG II hip implants. The products were recalled in July 2012 following a rise in the number of allegations including failures caused by corrosion, fretting, and loosening of the modular-neck stem, which have led to hip revision surgery and have also resulted in permanent injuries.