Stryker is one of the largest medical technology companies in the world. Among other products, they create artificial joints for replacement surgeries.
The ABG II modular-neck hip stem implants were made to allow surgeons to customize the replacement joint for each patient. The goal was to fit their existing bones better and allow for a fuller, more active life after surgery. Instead of a single neck that attaches to the femur (thigh bone) and rests on a cup attached to the pelvis, the ABG II system has multiple pieces that can be fit together.
The ABG II system consisted of 8 different “stems” and 10 “necks” that fit together to create the lower, femoral portion of the implant. This portion is, traditionally, a single piece that is attached to the femur. The different options for stems and necks allowed surgeons to assess the patient and create a piece that fit better than a traditional “one size fits all” implant.
In addition to being customized for the patient’s size and body, the system was created to last longer before requiring a second “revision” surgery. The implant was marketed to provide greater stability for the patient, post-surgery. The customizable femoral portion of the implant was also intended to reduce stress on the remaining bones as the patient became more active.
In 2012, Stryker voluntarily removed its ABG II modular-neck hip stem implants from the market. It recalled the implants because of “the potential for fretting and corrosion at the modular-neck junction which may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.”
The implants were introduced in 2009. They received 510(k) approval before reaching patients. This means that Stryker demonstrated to the United States Food and Drug Administration (FDA) that the implant was similar to other devices on the market that had passed FDA testing and did not require the same testing process. This allowed the devices to be used without clinical trials. While the process allowed the implants to be used, it did not indicate specific safety approval from the FDA.
The construction of the Stryker ABG II implants is not a traditional “metal-on-metal” implant where a metal ball rests in a metal cup/socket. Instead, when the modular neck is assembled, metal connects with metal, having virtually the same effect as a traditional metal-on-metal implant. This includes the corrosion of metal, releasing ions into the body with natural movement. As you walk and the implant works as it is meant to, microscopic metal pieces are chipped away from the motion. This “fretting” is what causes ALTR and led to Stryker’s decision to recall their implants.
If you were implanted with the ABG II Modular-Neck Hip System and have suffered complications, you may be entitled to compensation. Please call Estey and Bomberger at (800) 672-1036 to discuss and protect your legal rights.
