What Preceded the Stryker Hip Recall?

Following the Stryker hip recall there were many patients concerned about the potentially dangerous hip implant that resides in their body. Soon after the Rejuvenate and ABGII gained FDA approval—through the controversial 510(k) program—adverse reports began coming in to the FDA. The Rejuvenate was approved in 2008 and the ABGII in 2009 and were being marketed to surgeons and consumer by 2010. There were no clinical trials done to fully assess the safety of these two implant devices prior to the Stryker hip recall. Although before the Stryker hip recall, the company claimed these new hip devices would last from 15-20 years, some patients who had the implants less than a year suffered serious health problems.

Prior to the United States Stryker hip recall in July, 2012, Health Canada implemented a Stryker hip recall in May, 2012. Stating risks of corrosion and fretting which could lead to excess metal debris being released in the body, the Stryker hip recall left many patients feeling angry and frightened.  Since the Stryker hip recall, it was found that the Stryker hip implants were constructed using metal trunnions on either end of the neck piece. Those metal trunnions allowed body fluids to become trapped beneath, leading to further corrosion. Inflammation, infection and chronic pain resulted from that corrosion in many patients, causing deterioration of tissue and bone and the necessity of a revision surgery.

The Stryker recall also mentioned metal toxicity which occurs when the metal debris enters the bloodstream, causing such issues as: gastrointestinal disorders, neurological and cardiovascular problems, renal and thyroid issues, loss of hearing and vision, disruption of DNA, pseudo-tumor development, anxiety, irritability, memory loss, depression, vertigo and reproductive disorders. Following the Stryker hip recall, Stryker has claimed that excess weight, a history of diabetes, the patient’s ph levels, incorrect implantation techniques and patient infection could all contribute to medical issues. The implication is that the Stryker hip recall was merely a precaution rather than the serious medical issue it really is.