Scan. Plan. Mako Can.

IMPORTANT INFORMATION ABOUT HIP & 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, infection, 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 and/or foreign body sensitivity, soft tissue imbalance, osteolysis (localized progressive bone loss), audible sounds during motion, reaction to particle debris, and reaction to metal ions (ALTR). Hip and knee implants may not provide the same feel or performance characteristics experienced with a normal healthy joint.

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 doctor'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: 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.

IMPORTANT INFORMATION ABOUT HIP ARTHROSCOPY

Hip arthroscopy is performed in individuals to treat joint disease resulting from conditions such as femoroacetabular impingement, labral tears, removal of loose fragments of cartilage inside the joint, inflamed joint lining or painful bone spurs.

Hip arthroscopy surgery is often not considered to be appropriate for patients with certain types of infections, compromised bone stock, skeletal immaturity, severe arthritis of the joint or excessive body weight.

Like any surgery, hip arthroscopy surgery has serious risks which include, but are not limited to, pain, infection, bone fracture, peripheral neuropathies (nerve damage), circulatory compromise including deep vein thrombosis (blood clots in the legs), heart attack and death.

The information presented is for educational purposes only. Speak to your doctor to decide if hip arthroscopy surgery is appropriate for you. Individual results vary and not all patients will return to the same activity level. 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: Pivot Guardian, Together with our customers, we are driven to make healthcare better. All other trademarks are trademarks of their respective owners or holders.

IMPORTANT INFORMATION ABOUT ANKLE REPLACEMENT

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.

CP-AWI-1, 12-2015

IMPORTANT INFORMATION ABOUT SMART TOE II

Indications: The Memometal Intramedullary Bone Fastener (Smart Toe/X-Fuse) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.

Contra-Indications: Acute or chronic infections, local or systemic, surgical procedures other than those mentioned in the Indications section, do not use on patients allergic to the components of the product or having known allergies. Not indicated for patients with nickel sensitivity. The combination of this implant with implants of another origin is contraindicated.

IMPORTANT INFORMATION ABOUT TOETAC

Indications: The ToeTac™ Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

IMPORTANT INFORMATION ABOUT VARIAX

Indications: The Stryker Foot Plating System is intended for use in internal fixation, reconstruction or arthrodesis of small bones, including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures. Indications for VariAx 2 Plates include: The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including: • Replantation • Joint fusions • Corrective osteotomies • Osteopenic bone

Contra-Indications: 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

IMPORTANT INFORMATION ABOUT ANCHORAGE

Indications: The Anchorage Bone Plate Systems are indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist and ankles, finger and toes. The system may be used in both adults and pediatric patients.

Contra-Indications: The following contraindications may be of a relative or absolute nature and must be taken into account by the attending surgeons: Acute or chronic infections, local or systemic. Surgical procedures other than those mentioned in the Indications section. Do not use on patients allergic to the components of the product (Please see Instructions for Use) or having known allergies. The combination of this implant with implants of another origin is contraindicated.

IMPORTANT INFORMATION ABOUT EASYCLIP

Indications: The EasyClip staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Contra-Indications: The following contraindications may be of a relative or absolute nature, and must be taken into account by the attending surgeon. • Acute or chronic infections, local or systemic. • Surgical procedures other than those mentioned in the Indications section. • Do not use on patients allergic to the components of the product (Titanium-Nickel) or having known allergies.

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.

CP-AWI-9, 12-2016

IMPORTANT INFORMATION ABOUT INSPACE

The InSpace Implant is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.

The InSpace Implant is not appropriate for patients with certain types of infections, known or suspected allegories to the implant and/or instrument materials, or children.

The following information provided is based on data collected in the US Pivotal Clinical Study. There is evidence of increased risk of total adverse events of the affected shoulder compared to a partial rotator cuff repair, which were reported to be mostly mild to moderate in severity. Please note that complications reported by InSpace and Partial Repair patients were reviewed by a group of experts in shoulder surgery, and it was determined that none were related to the treatment devices (i.e., the InSpace Implant or devices used for Partial Repair). There is evidence of increased adverse events associated with a serious risk of the index shoulder which includes both medical and surgical treatments. The InSpace Implant is not fixed in place and may change position in the shoulder space. Movement out of the subacromial space and/or deflation of the InSpace Implant was observed in magnetic resonance imaging (MRI) 6 weeks post-operatively in up to half of patients. In these cases, it should be noted that no re-operations were required to remove the InSpace Implant.

The risks and benefits of the InSpace Implant in patients with the following conditions should be carefully considered: severe arthritis in the shoulder or full thickness cartilage loss, deltoid muscle defect or deltoid muscle paralysis, evidence that the shoulder is very unstable, missing or non-intact ligaments in the shoulder, known loss of sensation, major medical conditions such as blood clotting disorders, conditions that suppress the immune system or any other conditions that may compromise healing, safety and effectiveness of InSpace Implant use in patients below age sixty-five (65) has not been established, and safety and effectiveness of InSpace Implant use in pregnant or nursing mothers has not been evaluated.

If a reaction occurs, it will require follow-up with your surgeon. Some examples are as follows: irritation at the site where a cut was made during surgery, local infection, inflammation, and tissue damage where the InSpace Implant was implanted, or worsening of an existing infection. Additionally, movement of the implant out of its intended location may lead to worsening of your shoulder pain, discomfort, and/or stiffness which may require a re-operation, narcotic medications, non-narcotic pain medications, or post-operative shoulder injections.

As with any surgery, your surgical procedure may cause complications or adverse events. As with any shoulder surgery involving anesthesia there are potential risks and complications, including dizziness, fainting, difficulty breathing, wound infection, wound drainage, swelling, local pain, bleeding, bruising, surgical wound opening, nerve pain or injury which could result in partial or complete loss of movement in your affected arm, tendon injury, loss of sensation in your skin and muscle around your surgical site, inflammation of the tissues that surround your rotator cuff joint, a frozen rotator cuff (inability to freely move the shoulder joint) and delayed wound healing. There is a risk that a deep vein clot will form (thrombosis) and travel to the lung (pulmonary embolism), which could lead to stroke, heart damage or death. Any of the aforementioned complications/risks could require treatment such as medicine or additional surgery that may involve replacing or removing your InSpace Implant dependent on timeframe as the implant is biodegradable.

The information presented is for educational purposes only. Speak to your doctor to decide if you are interested in learning more about the InSpace Implant. Individual results vary and not all patients will receive the same postoperative activity level. It is important to follow your surgeon’s advice regarding after surgery care (for example, physical therapy) as well as which immediate activities you may or may not perform after receiving the InSpace Implant. Not following this advice may cause complications with the InSpace Implant. Some complications may require you to have additional surgery. Ask your doctor if the InSpace Implant 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: InSpace, Stryker, Together with our customers, we are driven to make healthcare better. All other trademarks are trademarks of their respective owners or holders.

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