Bunion surgery is intended for individuals with deformities of the first metatarsophalangeal joint (the joint at the base of the big toe). Based on a determination jointly made by a patient and a healthcare professional in consideration of a patient’s unique clinical factors, bunion surgery may be appropriate for certain individuals, and certain products, like those discussed below, may be used for treatment.
The PROstep MICA Screw System is intended to be used for fixation of bone fractures (e.g., repair of broken bones) or bone reconstruction (e.g. restoring shape, alignment or structure of a damaged, deformed or surgically altered bone).
The Ortholoc 2 Lapidus with Rotation System is intended to be used for the stabilization and fixation of fresh fractures, revision procedures, joint fusion (joining together), and reconstruction of bones of the feet and toes. Specific examples include: Arthrodesis (surgical fusion) of the first metatarsal cuneiform joint (base joint of the big toe).
The ProStep MICA Screw System and the Ortholoc 2 Lapidus with Rotation System are intended for patients in generally good health. The area treated should have good blood flow and normal nerve function. The skin must be healthy enough to fully cover the implant. The muscles and tendons should be strong enough to support normal movement. The bone also needs to be strong enough to hold the implant securely.
The Ortholoc 2 Lapidus with Rotation System and the PROstep MICA Screw System are not appropriate for patients who have certain types of infections, physiologically or psychologically inadequate patients (patients who have certain mental health conditions or physical conditions that may make them inappropriate candidates for surgery), patients with irreparable tendon system (tendons are so damaged they cannot be repaired), growing patients with open epiphyses (patients who’s bones are still growing), patients with high levels of activity, or patients that may benefit from more conservative treatment (such as footwear modification or physical therapy).
Any surgery has serious risks. The risks associated with the aforementioned product systems and/or procedures include but are not limited to infection, pain, swelling, and inflammation around the implant. Certain implant-related risks which may lead to revision of the implant or additional surgeries include implant fracture (breakage), loosening, dislocation (moving out of place). Additional risks include bone resorption (bone loss) or bone over-production (extra bone growth), allergic reaction to the implant materials, untoward histological responses possibly involving macrophages and/or fibroblasts (the body, including the body’s cells and tissues, may react abnormally to the implant over time), migration of particle wear debris possibly resulting in a bodily response (small pieces of the implant may wear off and migrate through the body resulting in a reaction), and embolism (blocked blood vessel). Additionally, delayed union (bone is taking longer than expected to heal), non-union (failure of bone to heal) or failure of the implant could occur.
The information presented is for educational purposes only. Stryker is not dispensing medical advice. Please speak to your doctor to decide if bunion surgery is appropriate for you. Only your doctor can make the medical decision about which products and treatments are right for your own individual condition. As with any surgery, bunion surgery carries certain risks. Your surgeon will explain all the possible complications of the surgery, as well as side effects. Additionally, the lifetime of an implant is not infinite and varies with each individual. Also, each patient will experience a different post-operative activity level, depending on their own individual clinical factors. Your doctor will help counsel you about how to best maintain your activities to potentially prolong the lifetime of the device. It is important to closely follow your doctor's instructions regarding post-surgery activity, treatment and follow-up care.
Stryker Corporation or its other divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Mica, Ortholoc, PROstep, Stryker. All other trademarks are trademarks of their respective owners or holders.
