Stryker Corporation’s Rejuvenate modular hip implant was approved for sale in the United States by the Food and Drug Administration (FDA) on June 3, 2008 and the ABGII was approved on November 4, 2009 as an extension of the Stryker Modular Hip approved in 2007. According to Stryker’s marketing materials, the purported benefits of the ABG II and Rejuvenate hips were enhanced stability, intraoperative flexibility and the ability to customize the hip to match a patient’s anatomy. Both the Rejuvenate and the ABG II were approved through a process that did not require pre-market clinical trials.
It did not take long before Stryker and the FDA began receiving reports of problems in patients with these hips. Due to the dual modular design, the modular junctions of the hip experienced fretting and corrosion that lead to excessive amounts of metal debris being shed from the implant into the area around the hip. The excessive metal debris in and round the hip joint leads to complications such as pain, fluid effusions, pseudotumor, swelling, metal ions in the blood stream and loosening of the implant. These problems can and frequently do lead to revision surgery many years earlier than anticipated.
In April 2012, Stryker issued an Urgent Field Safety Notice to surgeons and hospitals regarding the Rejuvenate and ABG II devices. In the notice, Stryker states that it had received reports of device failure due to metal debris contamination and refers to problems with fretting and corrosion. Stryker also states that patients had problems with tissues necrosis, metallosis, adverse soft tissue reaction and pseudotumor formation. Just three months after issuing the Urgent Field Safety Notice, Stryker issued a voluntary recall of all ABG II and Rejuvenate hips in the United States.
In addition, Stryker issued guidance to surgeons who had implanted the Rejuvenate and ABG II hips on how to monitor their patients for problems. Stryker recommended surgeons consider clinical examination such as blood work and cross section imaging regardless of whether a patient is experiencing pain or swelling. Stryker also recommends repeat follow-up examination even if there were no problems discovered at the initial exam. You can read more about Stryker’s recommendation on their website.