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Stryker’s Rejuvenate and ABG II modular-neck hip stems were marketed to patients with joint disease, arthritis, deformity, fractures and other issues that might complicate the use of a conventional hip implant. The modular design was marketed for its versatility in fitting the implant to each patient’s individual circumstances.
However, Stryker recalled both devices in June 2012 due to the risk of adverse side effects that could lead to device failure, one of several high-profile recalls of defective hip replacements.
In 2008, Stryker also recalled components of its Trident Acetabular system made in its Cork, Ireland facility after receiving a warning letter from the FDA due to its manufacturing process. The company said that the components were safe but did not meet certain internal quality guidelines.
Both the Rejuvenate and ABG II modular-neck hip stems are manufactured from a proprietary cobalt-chrome alloy that was said to provide enhanced durability. Like many metal-on-metal hip systems, however, the device poses a risk of side effects, such as metallosis and dislocation, due to metal fretting and crevice corrosion. These side effects in turn can lead to premature device failure.
Like many metal-on-metal hip systems, however, the device poses a risk of side effects, such as metallosis and dislocation, due to metal fretting and crevice corrosion.
Patients who believe they received one of the recalled implants should contact their surgeon immediately, regardless of whether they are experiencing pain, swelling, or other symptoms. If you did receive a Rejuvenate or ABG II system, a number of follow-up tests will help determine the proper course of action. Blood tests can help detect elevated levels of metal ions in the body. Imaging tests, such as X-rays, MRI, and ultrasound, can display physical side effects such as pseudotumors, heterotopic ossification, fracture, and dislocation.
Your surgeon will recommend a course of treatment that may ultimately include revision surgery, the replacement of the prosthetic with a new hip implant. Revision surgery is a more difficult procedure than an initial hip implantation and generally carries a longer recovery time.