Modular Neck Stem Voluntary Recall Information
The health and well-being of patients is, and has always been, Stryker’s top priority.
We have partnered with Broadspire Services, Inc., a third-party claims administrator, and are actively reimbursing affected patients for testing, treatment, revision surgery, if necessary, and other out-of-pocket costs relating to this voluntary recall.
Patients who have undergone total hip replacement and are unsure if they received a Rejuvenate or ABG II modular-neck stem should contact their surgeon to confirm the product implanted.
Stryker’s toll-free Patient Care Line can be reached by calling 1-888-317-0200 (U.S. and Canada only).
The Patient Care Line is available from 8am–9pm EST, Monday through Saturday.
Stryker initiated a voluntary recall of its Rejuvenate Modular and ABG II modular-neck hip stems in June 2012. This voluntary recall was initiated due to potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reaction, as well as possible pain and/or swelling, in or around your hip.
While modular neck hip stems provide surgeons with an option to correct certain aspects of a patient's anatomy and hip biomechanics, as part of Stryker's commitment to supporting the health and well being of patients we decided to voluntarily recall these modular-neck stem hip systems.
Stryker suggests that patients who have received a Rejuvenate or ABG II modular-neck hip stem contact their surgeon to schedule a follow-up appointment.
Stryker is committed to working with affected patients to address costs relating to this voluntary recall. Stryker has partnered with Broadspire Services Inc., a leading third-party claims administrator, to work directly with patients to manage medical claims and address out-of-pocket costs relating to this voluntary recall.
Patients should confirm that they have received a Rejuvenate or ABG II modular-neck stem.
Patients unsure if they received a Rejuvenate or ABG II modular-neck stem should contact their surgeon to confirm the product implanted.
Patients who have received a Rejuvenate or ABG II modular-neck stem should contact the Stryker Patient Care Line at 1-888-317-0200 (U.S. and Canada only).
A patient record (claim) will then be started, and you will be contacted by a claims representative from Broadspire.
Click here for the Patient Medical Authorization Form »
Click here for the Patient Reimbursement Procedure »
- Schedule an Appointment with your Surgeon.
If you received the Rejuvenate or ABG II Modular-Neck Hip Stem your surgeon will be able to evaluate how your hip implant is functioning and whether further testing is necessary.
In some cases, your surgeon may order blood tests or imaging to help evaluate your hip. You and your surgeon will determine the best care plan for you.
It is important that ALL patients who have received a Rejuvenate or ABG II modular-neck stem follow-up with their surgeon, even if they are not experiencing symptoms such as pain and/or swelling at or around their hip.
If you have further questions, please contact the Stryker Patient Care Line at 1-888-317-0200 (U.S. and Canada only). The Stryker Patient Care Line is available from 8am–9pm EST, Monday through Saturday.
At your follow-up appointment your surgeon may discuss with you any symptoms you may be experiencing, additional testing that may be appropriate, and your current post-operative plan.
Your surgeon may also order diagnostic testing to help evaluate your hip and determine future treatment recommendations.
Possible Follow-Up Tests
Your surgeon may choose to use several tests to evaluate your hip. These tests may include the following:
Your surgeon may order blood testing as part of your follow-up evaluation.
Your surgeon may choose to perform certain imaging on your hip, including X-rays, MRIs, or Ultrasound. These forms of diagnostic imaging may help your surgeon in evaluating your hip.
Additionally, your surgeon may advise further tests as part of the evaluation of your hip.
Your surgeon will evaluate how your hip is functioning and together you will decide on the best course of testing and/or treatment.
If Revision Surgery Is Necessary
Your surgeon may recommend an additional surgery to revise your current hip implant. This is called a revision surgery. A revision surgery is a second procedure performed to remove the old implants and replace them with new components.
Paying for Testing & Treatment
Stryker is committed to working with affected patients to address costs relating to this voluntary recall. To proactively manage the claims process, Stryker has partnered with a leading third-party claims administrator to work directly with patients to manage reimbursement of medical costs and address out-of-pocket costs relating to this voluntary recall.
Contact the Stryker Patient Care Line to Initiate a Claim with Stryker
Stryker is committed to working with patients to address medical costs relating to this voluntary recall. Stryker will be reimbursing patients for testing, treatment, revision surgery, if necessary, and other costs relating to this voluntary recall.
Broadspire Services Inc., Stryker's third-party claims administrator, will work directly with affected patients to address their out-of-pocket costs relating to this voluntary recall. Patients should contact the Stryker Patient Care Line at 1-888-317-0200 (U.S. and Canada only) for assistance. The Stryker Patient Care Line is available from 8am–9pm EST, Monday through Saturday.
Hip joint replacement is intended for use in individuals with joint disease resulting from degenerative and rheumatoid arthritis, avascular necrosis, fracture of the neck of the femur or functional deformity of the hip.
Knee joint replacement is intended for use in individuals with joint disease resulting from degenerative, rheumatoid and post-traumatic arthritis, and for moderate deformity of the knee. Joint replacement surgery is not appropriate for patients with certain types of infections, any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care, compromised bone stock, skeletal immaturity, severe instability of the joint, or excessive body weight.
Like any surgery, joint replacement surgery has serious risks which include, but are not limited to, pain, bone fracture, change in the treated leg length (hip), joint stiffness, hip joint fusion, amputation, peripheral neuropathies (nerve damage), circulatory compromise (including deep vein thrombosis (blood clots in the legs)), genitourinary disorders (including kidney failure), gastrointestinal disorders (including paralytic ileus (loss of intestinal digestive movement)), vascular disorders (including thrombus (blood clots), blood loss, or changes in blood pressure or heart rhythm), bronchopulmonary disorders (including emboli, stroke or pneumonia), heart attack, and death.
Implant related risks which may lead to a revision of the implant include dislocation, loosening, fracture, nerve damage, heterotopic bone formation (abnormal bone growth in tissue), wear of the implant, metal sensitivity, soft tissue imbalance, osteolysis (localized progressive bone loss), audible sounds during motion, and reaction to particle debris.
The information presented is for educational purposes only. Speak to your doctor to decide if joint replacement surgery is appropriate for you. Individual results vary and not all patients will return to the same activity level. The lifetime of any joint replacement is limited and depends on several factors like patient weight and activity level. Your doctor will counsel you about strategies to potentially prolong the lifetime of the device, including avoiding high-impact activities, such as running, as well as maintaining a healthy weight. It is important to closely follow your physician’s instructions regarding post-surgery activity, treatment and follow-up care.
Ask your doctor if a joint replacement is right for you.
Stryker Corporation or its other divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: GetAroundKnee, Mako, Mobile Bearing Hip, Stryker, Together with our customers, we are driven to make healthcare better. All other trademarks are trademarks of their respective owners or holders.
Stryker is a sponsor of the PGA TOUR. Hal Sutton and Fred Funk are paid spokespersons of Stryker, and their statements represent their personal views based on their personal experiences.