B.Braun BiCONTACT MS Aesculap Orthopaedics Mode D'emploi page 2

Hip endoprosthesis shaft
Intended use
• Component of a human hip endoprosthesis: Hip endoprosthesis shaft
• Combination with Aesculap hip endoprosthesis components
• Implant range: BiCONTACT® MS
• Implantation without bone cement
Materials
The materials used in the implant are listed on the package.
• ISOTAN®F titanium forged alloy Ti6Al4V according to ISO 5832-3
• PLASMAPORE® surface coating, pure titanium according to ISO 5832-2
BiCONTACT®, ISOTAN® 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:
• Degenerative osteoarthritis
• Femoral head necrosis
Contraindications
Do not use in the presence of:
• Possibility of reconstructive interventions for the treatment of the joint
illness, e.g. osteotomic resetting
• Acute or chronic infections near the joint, or systemic infections
• Secondary diseases that could influence joint implant functionality
• Systemic diseases and metabolic disorders
• Acute osteoporosis or osteomalacia
• Severely damaged bone structures that could prevent stable implantation
of implant components
• Bone tumors in the region of implant fixation
• Bone malformations, defective axial positioning, or other bone conditions
that rule out implantation of a hip-joint prosthesis
• Anticipated excessive load on the joint implant
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
Side-effects and adverse interactions
• Changes in position, loosening, wear and tear on, or fracture of implant
components
• Joint dislocation and postoperative changes in leg length
• Primary and secondary infections
• Venous thrombosis, lung embolism, and cardiac arrest
• Tissue reaction to implant materials
• Injury to blood vessels and nerves
• Hematomas and wound healing disorders
• Periarticular calcification
• Reduced joint mobility and flexibility
• Arthralgia and reduced tolerance for exercise
Safety notes
• Proper surgical performance of the implantation is the responsibility of
the operating surgeon.
• General risk factors associated with surgical procedures are not described
in the present 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.
• The operating surgeon must be thoroughly familiar with bone anatomy,
including the pathways of nerves, blood vessels, muscles and tendons.
• 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 instructions for use of the individual Aesculap implant components
must be observed.
• The implant components are tested and licensed for use in combination
with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
• Do not use damaged or surgically excised components under any
circumstances.
• Implants that have already been used must not be reused.
• 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.
• During the postoperative phase, in addition to mobility and muscle
training, it is of particular importance that the physician keeps the
patient well informed.
• 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.
• Only combine modular implant components with the appropriate
Aesculap hip endoprostheses.
• Observe material, friction coupling diameter and cone specifications.
• Observe further restrictions for combined implants.
• Avoid damaging the implant, especially in the neck or cone region, by
applying instruments (e.g. HF surgical devices) close to the implant.
Risk of implant component breakage due to
combination with implant components from other
manufacturers!
Use Aesculap implant components only.
CAUTION
Sterility
• The implant components come individually packed in protective
packaging that is labeled according to its contents.
• The implant components have been sterilized by irradiation (min. dose
25 kGy).
Danger to the patient and possible loss of implant
functionality due to resterilization!
Do not resterilize or reuse surface-coated
implants (PLASMAPORE®)
circumstances.
WARNING
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
expiry date or whose packaging is damaged.
Application
The operating surgeon shall devise an operation plan that specifies and
accurately documents the following:
• Selection of the implant components and their dimensions
• Positioning of the implant components in the bone
• Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
• All requisite implant components are ready to hand
• Operating conditions are highly aseptic
• The implantation instruments, including the special Aesculap implant
system instruments, are complete and in working condition.
• 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 familiar 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 operating procedure has been explained to the patient, whose
understanding of the following information has been documented:
• 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 insert can come loose due to excessive load, wear and
tear, or infection.
• The lifespan of the prosthetic joint depends on the body weight and the
load put on the joint.
• The prosthetic joint must not be subjected to overload through extreme
strain, or through work-related or athletic 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 shaft is a complex joint-replacement
operation; it is generally inferior to the primary joint replacement.
• The patient must undergo medical follow-up examinations of the
prosthetic joint at regular intervals.
The implantation and implantation site are prepared in the following way:
Following the femoral head osteotomy and after opening the medullary
cavity, prepare the femur with the BiCONTACT®-specific A and B
osteoprofilers.
Carry out intraoperative orientation of the implant components. When
doing this, pay attention to the resection line and the trochanter wing.
Select the implant according to B-osteoprofiler last introduced in the
correct position.
Before inserting the implants, carry out a test reposition and examine
joint mobility, joint stability and leg length.
Bone fractures in the implant site reduce the
viability of the implant anchorage.
Avoid bone fractures
operative techniques.
Treat bone fractures with appropriate intra-
WARNING
and postoperative therapies.
Handle the implant components properly.
Do not under any circumstances allow the implant surfaces to be
damaged.
Verify that the cone sizes of the prosthesis shafts are the same as the
cone sizes of the prosthesis heads (see cone size on the implant
packaging, e.g. 12/14 or 8/10).
Only remove the protective cap from the prosthesis cone immediately
before setting the prosthesis head in place.
Rinse, clean and dry the outside cone of the stem and, if necessary, the
inside cone of the prosthesis heads prior to setting the prosthesis head
in place.
Couple the prosthesis head and cone at room temperature only. If
necessary, allow the implant to cool to room temperature.
Before closing the wound, ensure, if necessary by means of an image
converter, that the implant components are correctly positioned.
To avoid abnormal wear and tear on the prosthesis: Remove any loose
bone cement or bone chips before closing the wound.
Further information on B. Braun/Aesculap implant systems can be obtained
from B. Braun/Aesculap or the relevant B. Braun/Aesculap agency.
TA-Nr.: 012639 06/08
under any
through careful