Stryker Rejuvenate and ABG-II Hip Recall
Stryker Rejuvenate and ABG-II modular-neck stems were recalled by Stryker Orthopedics on July 6. In issuing the recall, Stryker cited the danger posed by the modular-neck junction, where fretting and corrosion could occur. If this were to take place in a patient who had the device implanted, that person could expect to experience swelling, pain, loosening, compromised mobility, and a host of other complications. Given the threat posed by these defective items, it’s important to investigate what led us to this juncture.
The recalled units were brought to the market in 2009. At that time, it was hoped that the Rejuvenate and the ABG II would be a viable alternative to other hip prosthetics being offered. These customizable models were designed to fit better and last longer than other designs. Signs that something was amiss sprang up in April of this year, however, when Stryker put out an Urgent Field Safety Notice in relation to the Rejuvenate Modular Hip Implant System.
This consumer alert was necessitated due to the discovery that patients who had this system implanted could experience what’s known as metallosis. Should this malady affect an individual, they would be put at risk of sustaining bone and tissue damage, heightened levels of cobalt in the bloodstream, intense pain, immunological issues, and allergic reactions. This past May, Health Canada recalled the Stryker Rejuvenate because of an apparent need to correct the usage instructions of the device, and 60 adverse events have been reported to the Food and Drug Administration.
Should an adverse event take place, a painful revision surgery might be the only option for patients. Unfortunately, this operation has a much lower success rate due to the complexities inherent in the procedure. The device stem must be removed from its embedded position in the femur, and an additional component piece means there’s one more junction to deal with. This junction poses its own failure risks.
Our legal team is in the process of reviewing claims made by the patients implanted with the Stryker Rejuvenate and ABG II modular-neck stems who have experienced complications or device failure.