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.
IMPORTANT INFORMATION ABOUT HIP AND KNEE REPLACEMENT
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.
IMPORTANT INFORMATION ABOUT ANKLE REPLACEMENT
Indications: The Scandinavian Total Ankle Replacement (STAR™ Ankle) is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.
Contra-Indications: Active or prior deep infection in the ankle joint or adjacent bones, Skeletal immaturity, Bone stock inadequate to support the device including: Severe osteoporotic or osteopenia condition or other conditions resulting in poor bone quality , Avascular necrosis of the talus, Prior surgery and / or injury that has adversely affected ankle bone quality, Malalignment or severe deformity of involved or adjacent anatomic structures including: Hindfoot or forefoot malalignment precluding plantigrade foot, Significant malalignment of the knee joint. Insufficient ligament support that cannot be repaired with soft tissue stabilization, Neuromuscular disease resulting in lack of normal muscle function about the affected ankle, Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure, Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle, Prior arthrodesis at the ankle joint , Poor skin and soft tissue quality about the surgical site.
Common Side Effects from Total Ankle Replacement Surgery: For the first two weeks after surgery it is normal to have a moderate amount of pain. You may need to use pain medicine(s). This pain may slowly decrease over time, but it is not unusual to experience some discomfort for up to three months and swelling may continue for up to a year after surgery. Contact your surgeon right away if at any time you notice: Fluid leaking from your wound, Redness around your wound, Pain or swelling that starts suddenly (especially after an ankle twist or fall) or Severe pain after the initial two weeks following your surgery.
The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary arthrosis, previously infected arthrosis (second degree), revision of Failed Ankle arthrodesis, failed Total Ankle Replacement, avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis), Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle, rheumatoid arthritis with severe deformity such as rheumatoid hindfoot, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe endstage degenerative arthritis, severe defects after tumor resection pantalar arthrodesis.
Contraindications: The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include: any active or suspected latent infection or marked local inflammation in or about the affected area. Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site. Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices. Material sensitivity, documented or suspected. Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself. Patients having inadequate tissue coverage over the operative site. Implant utilization that would interfere with anatomical structures or physiological performance. Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care. Other medical or surgical conditions which would preclude the potential benefit of surgery. The T2 Ankle Arthrodesis Nail should NOT be used if following conditions are present: tibial malalignment of > 10˚ in any plane, severe vascular deficiency, osteomyelitis or soft tissue infection.
The information presented is for educational purposes only. Stryker is not dispensing medical advice. Please speak to your doctor to decide if joint replacement surgery is right for you. Only your doctor can make the medical judgment which products and treatments are right for your own individual condition. As with any surgery, joint replacement carries certain risks. Your surgeon will explain all the possible complications of the surgery, as well as side effects. Additionally, the lifetime of a joint replacement is not infinite and varies with each individual. Also, each patient will experience a different postoperative activity level, depending on their own individual clinical factors. Your doctor will help counsel you about how to best maintain your activities in order to potentially prolong the lifetime of the device. Such strategies include not engaging in high-impact activities, such as running, as well as maintaining a healthy weight.