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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.
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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.
Lawsuits, Settlements and Compensation
Under the terms of the recall, Stryker has offered to reimburse patients and surgeons for testing, treatment, revision surgery and other costs associated with the recall. The company has partnered with Broadspire Services, an independent third party that will evaluate patient claims. Broadspire is also employed by DePuy Orthopaedics, a division of Johnson & Johnson, to handle the recall of that company’s ASR (Articular Surface Replacement) hip replacement systems.
In December 2013, Stryker settled with four plaintiffs who brought cases against the company in New Jersey court, the first settlements in the suits over its Rejuvenate and ABG II hip systems. Two other cases in mediation did not result in a deal. Financial details of the settlements were not disclosed.
Before agreeing to the terms of Stryker’s recall, you should consult an attorney to assess your legal options and to ensure your legal rights are protected. Critics have accused DePuy and Broadspire of aggressively collecting patient medical data, overruling patient doctors by refusing to pay for revision surgery in some cases, and attempting to take advantage of patients who are unaware of their legal rights and the potential future cost of their implants.
In December 2013, Stryker settled with four plaintiffs who brought cases against the company in New Jersey court.
The terms of Stryker’s recall may be right for you. However, it is important that you make certain you have a full understanding of your options and the implications of any potential decision you make.
- Stryker SA. (2007, May). ABG™II modular anatomic reconstruction. Retrieved August 25, 2013
- Stryker Corporation. (2011, July). Rejuvenate Total Hip System surgical protocol. Retrieved August 25, 2013
- Meneghini, RM. (2012, April). Evaluation of painful total hip replacements: Modular metal taper junctions. Retrieved August 25, 2013
- U.S. Food and Drug Administration. (2013, January). Information for Patients Who Have Metal-on-Metal Hip Implants. Retrieved August 25, 2013
- Stryker UK. (2013, January 22). URGENT Field Safety Notice: RA 2012-067. Retrieved August 25, 2013
- Stryker Corporation. (2012, June). Rejuvenate modular / ABG II modular-neck stem voluntary recall. Retrieved January 14, 2014
- Markos, K. (2013, December 17). Stryker Corp. settles first batch of hip-implant lawsuits. The Record (Bergen County). Retrieved February 6, 2014
- Clarke, T. (2011, August 22). Insight: Depuy’s handling of hip recall sparks questions. Reuters. Retrieved January 14, 2014