Stryker Rejuvenate and ABG II Hip Replacement System Recall

Stryker Orthopedics is a leading medical technology company offering a myriad of medical products, including hip replacement devices. Reports of problems with a couple of those devices”the Rejuvenate and ABG II modular-neck hip systems”have led to a recent Stryker Rejuvenate recall.

On July 4, 2012, Stryker issued a voluntary product recall of these two systems, stating on their website that the potential risks of implantation included metal corrosion, which could lead to tissue reactions and pain and/or swelling.

Patients who have undergone hip surgery with one of these devices may be eligible for a Stryker Rejuvenate lawsuit.

Problems Reported with Metal-on-Metal Hip Implants

Numerous reports of problems with so-called metal-on-metal hip replacements have led to thousands of lawsuits around the country. Plaintiffs claim injuries that allegedly stem from the metal components rubbing against one another during normal wear and tear. Such friction can cause small shards of cobalt and chromium to migrate to the surrounding tissues, bone, and even into the bloodstream, causing numerous complications that can lead to hip failure and revision surgery.

The Stryker Rejuvenate and ABG II systems were not originally considered to be metal-on-metal devices, as they include a ceramic component and do not involve a metal ball rubbing against a metal socket. Unlike other devices, however, that offer a one-piece fixed femoral neck and stem, the Stryker modular-neck systems consist of two different metal components. Designed to allow for better precision and a more anatomically correct device, the components were originally thought to be the next advance in hip replacement. It was only later discovered that after implantation, the metal neck and stem could wear against one another, shedding metallic debris into the body.

Stryker Rejuvenate Recall in Response to Adverse Event Reports

When metal shards are released from the stem and neck wearing against one another, the resulting injuries can be extremely painful and destructive to the patient and the implant. The corrosion can cause small pockets of swelling, called “pseudotumors,” as well as massive soft tissue death, which can quickly lead to hip implant failure.

The FDA has reportedly already received more than 60 adverse event reports related to these devices, and the number of incoming reports is steadily increasing. Stryker had released a warning letter in April 2012 to distributors, hospital risk managers, and surgeons, indicating that patients could develop metallosis from these devices, which could then lead to complications like significant pain, tissue death, bone damage, immunological problems, and elevated blood levels of cobalt. In May 2012, Health Canada announced a Stryker Rejuvenate recall, during which the company planned to create and re-issue updated surgical implantation instructions. After the recall in the U.S., however, it seems that neither the Rejuvenate nor the ABG-II modular-neck hip systems will continue to be sold.

A Stryker Rejuvenate Lawyer Can Help

Patients who are experiencing pain and swelling, or who have had to go through revision surgery because of complications from the Stryker Rejuvenate or ABG-II hip systems, will likely benefit from a meeting with a Stryker Rejuvenate lawyer. A thorough review of the case may reveal claims that can be made against the manufacturer. If successful, a Stryker Rejuvenate lawsuit could result in monetary compensation. You deserve to have your rights respected. Please contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.