Stryker Rejuvenate Hip Implant Recall
Michael PhelanAugust 16, 2012 9:16 PM
(866) 735-1102 Ext 375
The Stryker Rejuvenate hip replacement device was designed and marketed as an alternative to the metal-on-metal hip implant devices that have dominated the medical device news lately. The Rejuvenate uses a ceramic component, so the ball and socket are not metal-on-metal. The device was marketed to younger patients as a hip implant that would fit better, last longer, and provide better range of motion.
So why did Stryker quietly recall the Rejuvenate hip replacement device in July 2012? It turns out that the Stryker Rejuvenate does have a metal neck that can rub against the metal stem and cause metal debris to come loose. Some Stryker Rejuvenate patients reportedly developed metallosis. Many medical professionals believe that metallosis is the result of metallic components within the body scraping and wearing together, causing tiny metalic particles to be released into the tissue surrounding a metal implant and into the blood stream. Metallosis can cause tissue damage, pain, pseudo-tumors, bone damage and failure of the hip joint. Some Stryker Rejuvenate patients had to have revision surgery to remove their Stryker Rejuvenate implants relatively soon after implantation. These implants were supposed to last longer than the 15 to 20 years that hip implants are expected to last.
What was Stryker's initial response to reports of device failure? Stryker's early reaction to the Rejuvenate failure rate was to accuse patients of not diligently rehabilitating their hips following surgery, or to blame surgeons for poor implantation technique. In a Product Correction Bulletin dated April 25, 2012, Stryker stated that factors such as diabetes and infection may have played a role in corrosion of the implants because such conditions can affect the pH of the tissue surrounding the implant.
However, that same month, April 2012, Stryker issued an urgent Safety Alert defining the potential hazards of its Rejuvenate Modular Hip System as follows:
Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space. Contact between metal ions and tissues and structures during an implant's service life may result in an Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (metallosis, necrosis, and/or pain). An ALTR may result in the need for revision surgery. Excessive fretting debris. Fretting may lead to increased metal debris in the joint space (concentration of debris exceeds individual patient threshold) resulting in osteolysis [bone dissolution]. Osteoloysis may be asymptomatic and may result in the need for revision surgery.)
Those are Styker's own words. The alternative to metal-on-metal implants may cause the same adverse tissue reactions- metallosis and osteoloysis- as the recalled DePuy Orthopaedics ASR implant and other problematic metal-on-metal implants.
In May 2012, the Canadian equivalent of the FDA announced that Stryker Rejuvenate was being recalled. Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck system from the U.S. market in July 2012. The reason given for the Stryker Rejuvenate recall was Stryker's concern for potential risks associated with the metal modular-neck stems, including the "potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions manifesting with pain and/or swelling." The Stryker website announcement is far less forthright than the April Satety Alert.
Patients are advised by Stryker that their Stryker Rejuvenate implant may be experiencing fretting and corrosion if the patient has symptoms of pain and/or swelling at the hip joint, in which case, patients should consult with their surgeon.
Any patient with a Stryker Rejuvenate Modualar Hip Implant should consult his or her hip surgeon. If you and your surgeon decide that the Stryker hip should be removed, please make sure that your surgeon and hospital are put on written notice that you want the explanted device preserved for evidence. Attorneys handling these product liability cases can send a preservation letter instructing the hospital on the preservation of the device.