In July, 2012, Stryker voluntarily recalled the Stryker Rejuvenate and ABG II hip implants because of the devices’ side effects caused by fretting and corrosion of its metal parts. These are not the first Stryker devices to have been recalled—there have been a number of product warnings and recalls in the past few years that have brought attention to the dangers of certain Stryker hip products.
In January, 2008, Stryker announced a voluntary recall of the Trident PSL and Hemispherical Acetabular Cups. The Trident Acetabular Cups are used in the socket of hip replacement implants. These components were manufactured in the company’s facilities in Cork, Ireland.
The company recalled the hip replacement parts after receiving a warning letter from the FDA regarding the conditions of their manufacturing facilities in Ireland and Mahwah, New Jersey. The FDA issued the warning letter in November 2007 after inspecting the Stryker manufacturing implant. The letter stated that the Stryker hip devices were not in conformity with the FDA’s manufacturing practices, and that “the firm has not prevented the recurrence of poor fixation of the hip implant component or prevented the failure to function which has resulted in revision surgeries.”
Stryker had been receiving complaints about problems with their devices since 2005. In particular, they have received complaints that the Trident PSL required revision surgery due to its failure and complications. Stryker Trident PSL and Hemispherical Acetabular Cups side effects include:
The FDA also cited faults in Stryker’s manufacturing, including problems with the methods, controls, and facilities used for storage and installation.
Specifically, the FDA cited the following violations:
In April, 2012, the UK’s health regulatory agency called for a ban on a combination of hip replacement parts: the Mitch TRH cup/heads made by Johnson & Johnson subsidiary, Finsbury Orthopaedics, and Stryker Accolade femoral stems. These metal-on-metal hip replacement parts used together brought unacceptably high rates of revision surgeries. After four years, 10.7 percent of patients with this combination of metal-on-metal hip parts required revision surgery.
The most recent Stryker recall affected the Stryker Rejuvenate and ABG II stems used in hip replacement implants. The devices lead to serious side effects, including inflammation and metallosis. Stryker has received over 45 adverse event reports associated with the device. The Stryker hip recall echoes the DePuy ASR hip recall in 2010. DePuy recalled its metal-on-metal ASR hip because of similar symptoms of metallosis and high failure rates, which led to patients undergoing revision surgery. These hip implant recalls have been at the heart of numerous studies, warnings and discussions as to the dangers of metal-on-metal hips.
If you were affected by the Stryker hip recall or experienced complications from another recalled hip implant such as the DePuy ASR, contact our firm immediately for a free case review by calling . You may be entitled to compensation for your medical expenses, lost wages, and pain and suffering.
In addition to the Stryker hip recall, our firm is also handling cases concerning other hip replacement products such as the DePuy Pinnacle metal-on-metal hips, the Wright Conserve hip implants, and the recalled Smith & Nephew metal hip implant liner.