Stryker, a leading medical technology company, creates products used around the country and world. Among the products they manufacture are artificial joints, such as hips.
The Rejuvenate modular-neck hip stem implants created by Stryker were intended to allow customizable joints for every patient. The aim was to allow surgeons to fit the implant to the patient’s natural bones better, which would allow for a fuller recovery and more active post-surgery life. Traditional implants are comprised of a single neck that is implanted into the femur (thigh bone), which rests on a cup attached to the pelvis. Alternatively, the Rejuvenate system is comprised of pieces that be fit together to create a custom neck piece for the device.
The Rejuvenate system consisted of 6 different “stems” and 16 “necks” that fit together to create the lower, femoral portion of the implant. This is the element, traditionally, that is a single piece, implanted on the femur. The Rejuvenate provided options for combining stems and necks. This permitted surgeons to assess the individual patient and craft a piece that fit his or her body more closely than a standard “one size fits all” implant.
In addition to creating a customized implant for the patient’s size and body, the system was intended to last longer before a second “revision” surgery was necessary. The implant was marketed to younger patients because of the expected lifespan of the new joint and the best range of motion possible for each patient. With so many options, the patient was supposed to have a more active life post-surgery than they may have with other implants.
In 2012, Stryker voluntarily recalled its Rejuvenate modular-neck hip stem implants from the market. The implants were recalled, according to Stryker’s website, due to “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 Rejuvenate implants were introduced to the market in 2009. They were used on patients after receiving a 510(k) approval. This approval means that Stryker demonstrated to the United States Food and Drug Administration (FDA) that the implant was similar enough to other devices already in use that had passed FDA testing that it did not need to undergo the same testing process. This allowed the devices to be implanted in patients without undergoing rigorous clinical trials. This process allows medical devices to be used, but it does not actually constitute the same safety approval from the FDA that tested products receive.
The Stryker Rejuvenate implants are not traditional “metal-on-metal” implants, with a metal ball fitted into a metal cup/socket. Instead, when the neck and stem are fitted together, the metals create a junction with essentially the same effect as other metal-on-metal implants. This includes the frequent side effect of the metal corroding, which chips off microscopic metal ions into the body as the patient naturally moves. This “fretting” results in ALTR and was the basis for Stryker’s recall of the Rejuvenate and ABG II implants.
If you received a Rejuvenate Modular-Neck Hip System implant 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.
