Recall of Stryker Rejuvenate and ABG II Modular-Neck Stems
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Written by: Heeso Kim
Stryker Orthopaedics voluntarily recalled two of its devices that are used
in artificial hip replacements: Rejuvenate and ABG II modular-neck stems.
This immediately removes both devices from the market and halts global
distribution. The decision to recall the stems may have been primarily
propelled from the complaints of patients who received Rejuvenate or ABG
II modular neck stems. According to the Food and Drug Administration (FDA),
there have been more than 60 adverse event reports that report patients
in pain and/or tissue swelling from these devices.
The company made an official statement that although the chances of medical complications due to these two devices are "very low," patients who experience symptoms of pain and/or swelling at the joint site of surgery should speak to their surgeons immediately. Even those who are not experiencing pain but have received a Rejuvenate Modular or ABG II modular-neck stem are still encouraged to contact their surgeons or the patient call center that the company has provided.
Stuart Simpson, Vice President and General Manager of Stryker Orthopaedics stated that following the market recall, the company "will work with the medical community to better understand this matter." Soon after the recall, Stryker issued a letter to surgeons in April 2012 regarding the risk of the modular-neck stems and their possible side effects.
Despite the recall and informational letters, the company has failed to address what may be the most important issue: an explanation of how these devices are causing the pain and/or swelling in patients. Studies suggest that these devices cause problems similar to what have been seen among patients who have received metal-on-metal hip implants. The Stryker stems may create metallic debris that not only potentially into the surrounding tissues, but also enter the bloodstream.
Our firm is disappointed to see yet another hip implant recall, but we are not surprised as the metal-on-metal designs were never tested. Internal corporate documents reveal that medical device manufacturers often emphasize a "rush to market" approach to compete with other manufacturers, and this is a priority over long-term safety. This corporate behavior was very evident in two recent multi-million dollar settlements we obtained with regard to cardiac difibrillators.