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Aesculap
TRJ 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 for stem with corundum blasted surface
Materials
The materials used in the implant are listed on the packaging:
■
ISOTAN®
titanium forged alloy Ti6Al4V acc. to ISO 5832-3
F
ISOTAN® is a registered trademark 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
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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Severe osteoporosis or osteomalacia
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Insufficient quality of the bone or osseous deformities, disorders in the implant fixation area which could impair
the stability of the fixation of the joint replacement primarily or over time
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Known hypersensitivity to the implant materials
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All areas of application not mentioned under 'Indications'
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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Disorders of 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 product in these cases requires the individual, critical assessment of the surgeon.
The revision of an endoprosthetic implant is also a difficult procedure with individual requirements that must be
appropriately assessed by the surgeon.
Side effects and interactions
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Changes in position, loosening, wear and tear on, or fracture of implant components
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Joint dislocation and postoperative changes in leg length
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Primary and secondary infections
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Venous thrombosis, lung embolism, cardiac arrest
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Tissue reaction to implant materials
■
Injury to blood vessels and nerves
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Hematomas and wound healing disorders
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Periarticular calcification
■
Reduced joint mobility and flexibility
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Arthralgia and reduced tolerance for exercise
Safety notes
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
■
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.
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The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
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The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
■
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 erroneous indication, wrong choice of implant,
incorrect combination of implant components and operating technique, the limitations of the treatment method,
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.
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Do not, under any circumstances, combine implant components from different manufacturers.
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Do not, under any circumstances, use damaged or surgically excised components.
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Implants that have been used before must not be reused.
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Combine modular implant components only with suitable Aesculap hip endoprostheses.
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Observe material, friction coupling diameter and cone specifications.
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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.
■
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.
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
■
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.
Risk of implant component breakage due to combination with implant compo-
nents 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 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!
►
Do not reprocess or resterilize the implants.
WARNING
Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
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Selection of the implant components and their dimensions
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Positioning of the implant components in the bone
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Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
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All requisite implant components are ready to hand.
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All requisite implantation instruments must be available and in working order, including special Aesculap joint
implantation instruments for preparation of the implantation site
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The operating surgeon and operating room team are thoroughly familiar with the operating technique, as well
as the sets of implants and implant instruments to be applied; complete information on these subjects must be
readily available at the workplace
■
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.
■
Clarification was obtained from the manufacturer in cases of an ambiguous preoperative situation and for
implants in the joint region to be provided for.
The surgical procedure and following information has been explained to the patient, and the patient's consent 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 can become loose owing to excessive load, wear and tear, or infection.
■
The service life of the prosthetic joint is determined by body weight and the amount of strain that is placed on
the joint.
■
The prosthetic joint replacement 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 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:
►
Perform a femoral head osteotomy and open the femur with an appropriate box osteotome.
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Prepare the medullary cavity with trimming rasps and, if necessary, drills of ascending sizes.
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Carry out intraoperative alignment of the implant components, observing the resection line.
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For cement-free implantation: Select the implant size equivalent to the size of the last profiler inserted 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 bed will affect the anchoring of the implants!
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Avoid bone fractures through careful operative techniques.
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Treat bone fractures by appropriate intraoperative and postoperative thera-
pies.
WARNING
►
Handle the implant components properly.
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Do not under any circumstances allow the implant surfaces to be damaged.
►
Verify that the cone size of the prosthesis stems are the same as the cone size of the prosthesis heads (see cone
size on the implant packaging, e.g. 12/14).
►
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 spheres prior
to setting the prosthesis head in place.
►
Attach the prosthesis head and prosthesis cone to each other 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 prevent abnormal wear and tear of the prosthesis: Prior to wound closure remove any exposed bone residues.
Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging.
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Implant Systems LLC
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA013111
2019-02
V6
Change No. 60083
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