Stryker Voluntarily Recalled Rejuvenate and ABG II
Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems and halted worldwide distribution of the products due to risk of injury. The devices could fret or corrode, harming body tissue and causing pain or swelling, according to Stryker. Some of the potential injuries and painful side effects include:
- Severe inflammatory reactions
- Pain in the groin
- Breakdown of muscles, tendons and other soft tissues in and around the hip joint
- Loss of surrounding bone
- Loss of mobility
Stryker Rejuvenate Side Effects Similar to Metal on Metal Hip Replacements
While other types of hip implants such as those made by Johnson & Johnson and DePuy Orthopaedics Inc. involve a metal ball rubbing against a metal socket, the Stryker Rejuvenate products involve a metal neck inside a metal stem. Plaintiff lawyers for a pending class action lawsuit against metal on metal hip replacement makers intend to include Stryker Rejuvenate in their suit.
Stryker has argued that its product is different from other metal on metal hip replacements, yet plaintiff attorneys say that in spite of that difference, the tissue injury risks associated with the recalled Stryker Rejuvenate products are the same as those associated with other implants.
Stryker states that the rate of complications arising from the recalled devices was "extremely low." The company based its recall decision on information collected since the products hit the market, saying it "may be predictive of a trend." It instructed patients implanted with the devices to contact their surgeon.
There have been at least 45 adverse events reported to the U.S. Food and Drug Administration (FDA) regarding the Stryker Rejuvenate modular-neck stem since the beginning of 2012, according to PRWEB.