The Stryker Rejuvenate and ABG II modular-neck stems were recalled July 6, 2012, due to concerns that the hip replacement systems could risk the patients’ health.
The manufacturer of these products, Stryker Orthopaedics, has reportedly received 60 reports of adverse events related to these devices. The company’s concern is that the modular-neck stems could actually harm some recipients of the implant.
The reports indicate that fretting and corrosion could occur at the modular-neck stems, which could cause pain and swelling in the surrounding tissue. Patients who experience these symptoms, or immobility or premature loosening of the implant may need revision surgery.
The affected models were introduced in 2009
Stryker marketed them as a longer-lasting and more customizable alternative to other hip prosthetic systems on the market. It was originally argued that these devices were safer than other metal-on-metal implants because of their design, but experts now believe metal components of these systems also rub together and cause elevated levels of cobalt in the blood.
Modular systems also have an additional component that adds another junction and increases the chance of weakness and device failure.
Stryker released an “Urgent Field Safety Notice” in April 2012 reporting patients with the Rejuvenate Modular Hip Implant System could develop metallosis, which can cause pain, allergic reactions, bone damage, immunological problems, and tissue damage.
The Stryker Rejuvenate was then recalled in Canada in May 2012 in order to provide new instructions for use
Because the stem is embedded in the femur bone, revision surgery for this type of hip replacement could be much more complicated than it would be for other implants. Any type of revision surgery for a hip replacement is more complicated than the initial procedure, and has a higher risk of failure.
Product Liability Lawyers Located in Bellevue, Olympia, and Vancouver, WA
We are looking into cases of patients who have experienced the symptoms of metallosis after receiving a Rejuvenate Modular Hip Implant.