B.Braun BiCONTACT Aesculap Mode D'emploi/Description Technique page 2

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Aesculap BiCONTACT®
BiCONTACT® hip endoprosthesis stem
Intended use
The implant is used
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as a component of a human hip endoprosthesis: Hip endoprosthesis stem
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to combine with Aesculap hip endoprosthesis components
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for implantation without bone cement with PLASMAPORE® or PLASMAPORE®
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for implantation with bone cement, for uncoated stem
The implant range consists of BiCONTACT®, BiCONTACT® S, H, MS, SD, D, N, E, EH and BiCONTACT® Revision.
Materials
The materials used in the implant are listed on the packaging:
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ISOTAN® titanium forged alloy Ti6Al4V acc. to ISO 5832-3
F
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ISODUR® cobalt-chromium forged alloy CoCrMo according to ISO 5832-12
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PLASMAPORE® surface coating pure titanium acc. to ISO 5832-2
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PLASMAPORE® surface coating pure titanium acc. to ISO 5832-2 with additional calcium phosphate coating
µ-CaP
BiCONTACT®, ISOTAN®, ISODUR® and PLASMAPORE® are registered trademarks of Aesculap AG, 78532 Tuttlingen /
Germany.
Indications
Use for acute disorders of the hip that cannot be treated by other therapies:
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Degenerative osteoarthritis
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Rheumatic arthritis
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Fractures of the joint
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Femoral head necrosis
Risk of aseptic implant loosening when using bone cement with uncoated
BiCONTACT® prosthesis shafts made of ISOTAN®!
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Do not use uncoated BiCONTACT® prosthesis shafts made of ISOTAN® (tita-
nium forged alloy ISO 5832-3) for implantations with bone cement.
WARNING
Exceptional indications: Patients with proven foreign-body sensitivity for the alloy elements nickel, cobalt or chro-
mium, coinciding with indication for prosthesis stem anchoring with bone cement.
Indications for using stem type BiCONTACT® Revision in surgery to replace hip
endoprosthesis stems
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Cement-free revision operations
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Periprosthetic fractures
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Subprosthetic fractures
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Treatment of large bone defects on the proximal femur
Contraindications
Absolute contraindications
Do not use in the presence of:
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Joint diseases that can be treated by reconstructive surgery (e.g. displacement osteotomy)
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Acute or chronic infections near the joint, or systemic infections
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Secondary diseases that could influence joint implant functionality
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Acute osteoporosis or osteomalacia
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Poor bone quality as well as osseous deformations, diseases in the area of the implant anchors, which could
affect the primary or future status of anchor stability of the joint replacement.
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Known hypersensitivity to the implant material.
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Prosthesis heads with XXL neck length in combination with BiCONTACT® H cementless, SD, D, N, E, EH,
BiCONTACT® Revision and NK508T (BiCONTACT® S cementless size 8)
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All of the areas of application not listed under the indications.
Implant failure due to excessive body weight of the patient and mainly distal fix-
ation of the small BiCONTACT® implants!
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Avoid distal implant anchoring by appropriate bone preparation.
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Drill open the distal marrow cavity, using flexible marrow cavity drills.
WARNING
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Ensure sufficiently deep prosthesis seat through proximal-medial support.
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Carry out intraoperative check of the prosthesis seat, using an imaging device.
Observe the maximum allowable body weight of the patient for distal implant fixation: 50 kg for NK709T and
NK710T (BiCONTACT® SD sizes 9 and 10), 60 kg for NJ208T, NJ209T, NJ210T (BiCONTACT® D sizes 8, 9 and 10),
NJ628T (BiCONTACT® EH sizes 8) and 65 kg for NK210T (BiCONTACT® Revision SD size 11).
Relative contraindications
The following conditions, individual or combined, can lead to delayed healing or compromise the success of the oper-
ation:
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Anticipated excessive load on the joint implant
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Pronounced osseous deformities
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Disruption of the bone metabolism
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Dependency on pharmaceutical drugs, drug abuse, or alcoholism
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Expected lack of patient cooperation
Use of the products requires individual, critical assessment by the surgeon.
Even the change of an endoprosthetic implant is a complicated procedure with individual preconditions which must
be assessed accordingly by the surgeon.
Side effects and interactions
Always consider current known possible risks, including resulting clinical consequences regarding the use of the
product.:
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-coated stem
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µ-CaP
Safety notes
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Sterility
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Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
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The following conditions must be fulfilled prior to application:
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The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
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Changes in position, loosening, wear and tear of, or fracture of implant components
Joint dislocation and postoperative changes in leg length
Primary and secondary infections
Thromboses, embolisms
Tissue reaction to implant materials
Injury to the surrounding tissue, including nerve and vascular damage
Hematomas and wound healing disorders
Periarticular calcification
Reduced joint mobility and flexibility
Limited resilience of the joint and joint pain
It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
General risk factors associated with surgical procedures are not described in this documentation.
The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
The operating surgeon is responsible for combining and implanting the implant components, with or without
bone cement.
Aesculap is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant,
incorrectly combined implant components and/or operating techniques, the limitations of treatment methods,
or inadequate asepsis.
The user instructions for individual Aesculap implant components must be followed.
The implant components were tested and approved in combination with Aesculap components. If other combi-
nations are used, the responsibility for such action lies with the operating surgeon.
Do not, under any circumstances, combine implant components from different manufacturers.
Do not, under any circumstances, use damaged or surgically excised components.
Implants that have been used before must not be reused.
Damage to load-bearing bone structures can result in loosening of the components, bone or implant fractures
or other acute complications.
To ensure the earliest possible detection of such catalysts of implant dysfunction, the prosthetic joint must be
checked periodically, using appropriate techniques.
Combine modular implant components only with suitable Aesculap hip endoprostheses.
Observe material, friction coupling diameter and cone specifications.
Observe further restrictions for combined implants.
Avoid damage to the implant, especially in the neck or cone region, caused by instruments (e.g. HF surgical
devices) applied close to the implant.
The implant has not been evaluated for safety and compatibility in the MR envi-
ronment. It has not been tested for heating, migration or image artifact in the MR
environment. Scanning a patient who has this implant may result in patient injury.
WARNING
Risk of implant component breakage due to combination with implant compo-
nents from other manufacturers!
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Use Aesculap implant components only.
CAUTION
The implant components applied, along with their article numbers, the name of the implant, as well as the batch
number and serial number (if available) must be documented in all patient records.
Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
The implant components come individually packed in protective packaging that is labeled according to its con-
tents.
The implant components are sterilized by irradiation.
Store implant components in their original packaging. Remove them from their original protective packaging
only just prior to application.
Prior to use, check the product expiry date and verify the integrity of the sterile packaging.
Do not use implant components that are past their expiration date or whose packaging is damaged.
Damage to implants caused by processing and resterilization!
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Do not reprocess or resterilize the implants.
WARNING
Selection of the implant components and their dimensions
Positioning of the implant components in the bone
Location of intraoperative landmarks
All requisite implant components are ready to hand.
All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
The operating surgeon and operating room team are thoroughly conversant with the operating technique and
with the available range of implants and instruments; information materials on these subjects must be complete
and ready to hand.
The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
The functionality of the prosthetic joint is essentially inferior to that of the natural one.
The prosthetic joint can bring about only limited improvement in the patient's condition vis-à-vis their condition
prior to the operation.
The prosthetic joint can come loose due to excessive load, wear and tear, or infection.
The lifespan of the prosthetic joint depends on the patient's body weight and the strain to which the joint is
subjected.
The prosthetic joint must not be overstrained by extreme loads, hard physical labor or sporting activities.
Corrective surgery may become necessary if the implant loosens.
In the event that corrective surgery is performed, it may not be possible under certain circumstances to restore
joint mobility and flexibility.
The revision of a hip endoprosthesis stem is a complex joint replacement operation.
Generally, the revision joint replacement will be inferior in its performance to the primary joint replacement.
The patient must undergo medical follow-up examinations of the prosthetic joint at regular intervals.