On July 6, 2012, Stryker Orthopaedics issued a recall of two modular hip stem replacements. The recall included all lots of the Rejuvenate Modular and the ABG II Replacement Hip Systems. The Rejuvenate Hip is different from other hip replacement devices because it is not a typical metal-on-metal hip replacement. Instead, the Rejuvenate uses a ceramic component in association with a metal component that is custom-made in an effort to fit patients better. Originally, the Rejuvenate was projected to be able to last for 15 to 20 years, but many are failing in under just five years.
The failures are due primarily to patients' development of "metallosis," or metal poisoning, which is an adverse tissue reaction caused by a buildup of heavy metals in the body. The Rejuvenate Hip has been voluntarily recalled by its manufacturer, Stryker, due to the risk for metallosis cause by fretting and corrosion. Metallosis can lead to:
- Pain/Inflammatory reaction
- Breakdown of muscles and tendons
- Dissolution of the bone
- Chromosomal Aberrations
- Loss of surrounding bone
As a hip replacement patient, any news of a new hip implant recall can be unsettling. It can lead you to wonder things such as whether the replacement has been inserted into your body, whether you will suffer from an adverse event, and what you can do to protect yourself. Before you can do anything, however, you need to know what you are dealing with and what your options may be now and in the future.
If you have received a hip implant and think that a Stryker modular hip stem replacement may have been used in your surgery, then it is important to know that:
- Only the Stryker Rejuvenate Modular and the ABG II modular hip stems have been recalled.
- Your surgeon can confirm whether one of these hip stems was used during your surgery.
- The recall occurred because post-market surveillance data suggested that fretting and corrosion associated with these devices could be indicative of a trend.
- Fretting and corrosion could lead to tissue pain and swelling.
- At least 45 adverse events were reported to the FDA in the first six months of 2012.
Hip Implant Defects Attorneys
Please contact us if you or someone you know has experienced "metallosis" or the possible need for additional surgery associated with the use of a Stryker Rejuvenate defective hip replacement component(s).