Integra Cadence Total Ankle System Manual page 4

EN – ENGLISH
The Cadence Total Ankle System is also indicated for revision
surgeries following failed total ankle replacement and non-
union/mal-union of ankle arthrodesis, provided sufficient
bone stock is present.
Note: In the United States, this device is intended for
cemented use only.
Note: Outside the United States, this device is intended for
cemented or cementless use.
Contraindications
The Cadence Total Ankle System is contraindicated for:
• Active Infection
• Skeletally immature
• Pregnancy
• Suspected or documented metal allergy or intolerance
• Severe avascular necrosis of the talus/tibia
• Severe malalignment or instability that is not surgically
correctable
• Neurological or musculoskeletal disease that may
adversely affect gait or weight bearing
• Participation in activities that may exert excessive loading
on joint area and prosthesis
• Inadequate neuromuscular status (e.g., prior paralysis,
neuropathy)
• Poor bone stock, poor skin coverage, or excessive bone
loss around the joint which would make the procedure
unjustifiable
• Obesity
• Steroid use
The following conditions present an increased risk of failure:
2
• Severe osteoporosis; marked bone loss or revision
procedures for which an adequate fit of the prosthesis
cannot be achieved
• Osteomalacia
• Metabolic disorders
• Demonstrates physiological or anatomical anomalies
• Undergoing immunosuppressive therapy
• Malignancy/local bone tumors
• Compromised wound healing
• History of mental illness/instability and non-compliance
• History of drug abuse and/or addiction
Warning: This device is not intended for subtalar joint fusion
or subtalar joint impingement. Please carefully evaluate the
anatomy of each patient before implantation.
Precautions
• Each patient must be evaluated by the surgeon to
determine the specific risk/benefit relationship in light
of the patient's condition and the surgeon's practice,
training, experience, and knowledge of the related
medical literature.
• The surgeon should discuss with the patient prior
to surgery possible risks, precautions, warnings,
consequences, complications, and adverse reactions
associated with the surgical procedure and implantation
of the device.
• Patients need to be informed regarding expectations
pertaining to performance and limitations following
surgery. The prosthesis does not replace normal bone,
has a finite service life, and future revision surgeries may
be necessary.