Integra Cadence Total Ankle System, Manual

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3
EN – ENGLISH
• Excessive loading or trauma may cause premature failure
of the prosthesis.
• Do not attempt a surgical procedure with faulty,
damaged or suspect instruments or implants. Inspect all
components preoperatively to assure utility.
• An adequate inventory of sterile implant sizes should be
on hand at the time of surgery to ensure the optimum size
for the patient.
• Opening of the instruments set must be done according
to aseptic condition.
• 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.
• 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.
• 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.
• 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:
• Pain, discomfort, or abnormal sensations due to presence
of the implant;
• Bending, loosening, and/or breakage;
• Risk of additional injury from post-operative trauma;
• Migration of the implant position or implant material
resulting in injury;
• Bone loss due to stress shielding
Side effects may include but are not limited to:
• Infections;
• Hematoma;
• Allergy;
• Thrombosis;
• 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.