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Obesity
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Steroid use
The following conditions present an increased risk of failure:
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Severe osteoporosis; marked bone loss or revision procedures for which an
adequate fit of the prosthesis cannot be achieved
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Osteomalacia
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Metabolic disorders
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Demonstrates physiological or anatomical anomalies
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Undergoing immunosuppressive therapy
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Malignancy/local bone tumors
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Compromised wound healing
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History of mental illness/instability and non-compliance
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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
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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.
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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.
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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.
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Excessive loading or trauma may cause premature failure of the prosthesis.
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Do not attempt a surgical procedure with faulty, damaged or suspect instruments or
implants. Inspect all components preoperatively to assure utility.
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An adequate inventory of sterile implant sizes should be on hand at the time of
surgery to ensure the optimum size for the patient.
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Opening of the instruments set must be done according to aseptic condition.
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When handling the implants, avoid any contact with other material or tools which
may damage the implant surface. Under no circumstances should the implant be
modified. Damage sustained to the surface of the implant may lead to implant
fracture and/or particulate debris.
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Care must be taken that the correct and appropriate size implant is used in
conjunction with the correct instrumentation and trial components. Incorrect
sizing may lead to reduced efficacy of the implant.
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When performing total ankle replacement, Cadence Total Ankle System may not
be used in conjunction with other Integra implant systems unless indicated or with
implants produced by other manufacturers.
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No surgical implants should be reused. Any implant, once used, should be discarded.
Even if it appears undamaged, it may already have small defects and internal stress
patterns which may lead to implant fracture, fatigue failure, and/or particulate
debris. Reuse of the implant may cause infection to the patient.
Adverse Effects
Complications with the use of joint prosthesis have been reported in the medical
literature. Any patient undergoing a surgical procedure is subject to intra-operative
and post-operative complications. Each patient's tolerance to surgery, medication, and
implantation of a foreign object may be different.
Possible risks, adverse reactions, and complications associated with surgery and the
use of the prosthesis should be discussed with and understood by the patient prior to
surgery.
Complications may include but are not limited to:
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Pain, discomfort, or abnormal sensations due to presence of the implant;
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Bending, loosening, and/or breakage;
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Risk of additional injury from post-operative trauma;
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Migration of the implant position or implant material resulting in injury;
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Bone loss due to stress shielding
Side effects may include but are not limited to:
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Infections;
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Hematoma;
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Allergy;
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Thrombosis;
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Bone non-union or delayed union
Adverse effects may necessitate re-operation, revision or removal surgery, arthrodesis
of the involved joint, and/or amputation of the limb. Implant removal should be
followed by adequate post-operative management to avoid fracture or re-fracture.
MDR Reporting Reminder: Medical device manufacturers and users are required by law
and regulation to report serious injuries and death.
Post-Operative Care
Preventative actions for the patient to avoid post-operative complications:
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Avoid extreme motion in flexion-extension.
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Wear external immobilization (plaster, splint, etc.) according to the surgeon's
prescription.
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Receive prompt medical attention for any infection that could occur, whether at
the operated-member level or elsewhere in the body.
The patient should be encouraged to report to his/her surgeon any unusual changes of
the operated extremity. If evidence suggests loosening of the implant (particular pain
and progressive changes in the radiographs), an intensified schedule of check-ups is
advised and new warning and instructions to the patient may be appropriate regarding
further activity restrictions.
Excessive physical activity and trauma affecting the operated extremity have been
implicated in the premature failure of joint arthroplasty as a result of position change,
fracture and/or wear and tear of the implant.
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