IMPORTANT INFORMATION ABOUT HIP AND KNEE REPLACEMENT


U.S. Modular Hip Settlement Program

Stryker's Voluntary Recall of Rejuvenate and ABG II Modular-Neck Hip Stems


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.

GSNPS-PE-26-A

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.

CP-AWI-1, 12-2015



IMPORTANT INFORMATION ABOUT WRIST REPLACEMENT

VariAx 2 Wrist Fusion System

Indications: The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:

  • Post-traumatic arthritis of the joints of the wrist
  • Rheumatoid wrist deformities requiring restoration
  • Complex carpal instability
  • Post-septic arthritis of the wrist
  • Severe unremitting wrist pain related to motion
  • Brachial plexus nerve palsies
  • Tumor resection
  • Spastic deformities

Contra-Indications: The physician’s education, training and professional judgment 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
Source: VAX-ST-23


ReMotion Total Wrist System

Indications: The ReMotion Total Wrist System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

Contraindications: Bone, musculature, tendons, or adjacent soft tissue compromised by disease, infection, or prior implantation, which cannot provide adequate support or fixation for the prosthesis.

  • Known sensitivity to materials used in this device
  • Skeletal Immaturity
Source: V15114

The information presented is for educational purposes only. Stryker is not dispensing medical advice. Please speak to your doctor to decide which type of 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 surgery 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 product 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 in order to potentially prolong the lifetime of the device.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: ABG, GetAroundKnee, Mako, Rejuvenate, ReMotion, STAR, Stryker, T2, Together with our customers, we are driven to make healthcare better, VariAx. All other trademarks are trademarks of their respective owners or holders.
Content ID: REM-AWI-1, 01-2017



IMPORTANT INFORMATION ABOUT SHOULDER REPLACEMENT

ReUnion System Indications for Use:

For use as a Hemi or Total Shoulder Replacement: Aseptic necrosis of the humeral head; Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis; Proximal humeral fracture and/or dislocation; Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use. In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

ReUnion Reverse Arthroplasty System (RSA): The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s). Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis; Proximal humeral fracture; Revision of previously failed shoulder joint replacement; Glenoid Baseplate components are intended for cementless use with the addition of screw fixation; The Humeral Stem components are intended for both cemented and cementless use; In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.

In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement: Aseptic necrosis of the humeral head; Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or posttraumatic Arthritis; Proximal humeral fractures and/or dislocation; Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate. The glenoid components are intended for cemented use only. When used with ReUnion RSA Humeral and Glenoid Components

The ReUnion RFX System, when used with ReUnion RSA humeral and glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s). Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis; Proximal humeral fractures; Revisions of previously failed shoulder joint replacements.

In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s). Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. Source: Stryker Instructions for Use K161863


The information presented is for educational purposes only. Stryker is not dispensing medical advice. Please speak to your doctor to decide which type of 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 surgery 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 product 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 in order to potentially prolong the lifetime of the device.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: ReUnion, SmartLock, SOMA, Stryker, X3. All other trademarks are trademarks of their respective owners or holders.
Content ID: RU-AWI-1, 05-2017

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