Stryker’s “Rejuvenate Modular Primary Hip System”, “Rejuvenate Total Hip System” and ABG II System are now been recalled for possible side-effects similar to those seen in metal on metal hip implants. Hip implants like the “Rejuvenate” system are used for correcting joint failure caused by a variety of conditions like osteoarthritis.
The indications for the total hip replacement include:
The “Stryker Rejuvenate” system, released in February of 2010, is a modular system designed to re-create a patient’s original hip with mixed and matched necks and stems composed of cobalt and chromium in the neck and a titanium coating on the stem. According to a study released in April of 2012, “corrosion remains the chief culprit in the failure of modular implants…” with this corrosion occurring at the “neck-stem interface” rather than the neck-head interface as seen in metal on metal hip implants. The study also states that the fretting and crevice corrosion seen in modular systems like the “Stryker Rejuvenate” hip implant are real rather than theoretical concerns.
The Stryker Rejuvenate Modular Hip System was approved by FDA through a procedure called the 510(k) process. Pre-Market Notification or 510(k) was established to streamline the process for new medical devices that were “substantially equivalent” to devices – called “predicates” in the approval process.
The predicate for the Stryker Rejuvenate Modular Hip System, a modular component system, was the Wright Pro-Femur modular component. The Pro-Femur has had serious issues with corrosion at the modular sites resulting in a whole host of problems including fractures and adverse tissue response. Predictably, there are similar adverse reports for the Rejuvenate Modular Hip. These problems led Stryker to issue an Urgent Safety Alertin April 2012 to warn Surgeons about the difficult nature of these implants that have resulted in corrosion and related problems at the modular sites.
Design issues are a key factor in these devices, but so too is the choice of materials. Using the combination of titanium (Ti) and cobalt chromium (CoCr) in a modular implant can, and apparently has resulted in corrosion. In addition, it exposes patients to potential multi-organ injuries from the release of heavy metals into the body.
Experience with devices such as the Stryker Rejuvenate Modular Hip System is disclosing a number of problems and have caused injuries to patients, as well as requiring painful additional surgical operations to remove the devices.
The attorneys at Raphaelson & Levine are filing Stryker lawsuits on behalf of injured parties across the country. If you or a loved one has suffered an injury due to a Stryker Rejuvenate Modular Hip System, contact Raphaelson and Levine today to discuss your claim 212-268-3222.