Stryker Orthopaedics recalls their hip replacement Rejuvenate Modular and ABG II modular-neck hip stems.
On July 6, 2012, Stryker Orthopedics issued a recall of their hip replacement Stryker Rejuvenate and ABG II modular-neck stems. The company has indicated that the recall of this hip replacement system is due to the potential risks associated with modular-neck stems. These risks include the potential for fretting and corrosion at the modular-neck junction, which may cause local tissue reactions with pain and swelling. Patients with this implanted hip replacement system may now have pain, swelling, immobility, premature loosening, or other complications that may potentially require revision surgery. Revision surgery for a hip replacement is much more complicated and generally less successful than a first hip replacement.
The Rejuvenate and ABG II models entered the market in 2009. These Stryker products were promoted as enabling surgeons to customize the implant to each patient with an expected better and longer lasting fit than other hip prosthetic models on the market. However, in April 2012, Stryker Orthopedics issued an "Urgent Field Safety Notice" indicating that patients could potentially develop metallosis from the Rejuvenate Modular Hip Implant System, which could lead to complications such as bone damage, immunological problems, significant pain, allergic reactions, tissue damage, and increased blood levels of cobalt. In May 2012, Health Canada announced a Stryker Rejuvenate recall for the purpose of providing updated instructions for use. To date, the FDA has received over 60 adverse event reports related to these devices.
This product was withdrawn a week ago. The revision surgery with this system is much more complicated than our other hip cases because the stem is involved which is imbedded in the femur and thus less successful.
We are investigating cases on behalf of patients who have received a Stryker Rejuvenate or ABG II modular-neck stem and who are experiencing pain, swelling, immobility, premature loosening, or other complications.
Call or email LT Pepper Law for a consultation.
267-415-4414
ltp@ltpepperlaw.com
