Publicité
Les langues disponibles
Les langues disponibles
®
Aesculap
Metha®
Metha® short stem prosthesis
Intended use
The implant is used
■
as a component part of a human hip endoprosthesis: hip endoprosthesis stem,
■
in combination with other Aesculap hip endoprosthesis components,
■
for implantation without bone cement.
Materials
The materials used in the implant are listed on the packaging:
■
ISOTAN®
titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
■
PLASMAPORE®
surface coating pure titanium acc. to ISO 5832-2 with additional calcium phosphate coating
µ-CaP
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
■
Rheumatic arthritis
■
Femoral head necrosis
Contraindications
Absolute contraindications
Do not use in the presence of:
■
Joint diseases that can be treated by reconstructive surgery (e.g. displacement osteotomy)
■
Existing infections near the joint, or systemic infections
■
Secondary diseases that could be expected to influence the joint implant functionality
■
Insufficient quality of the bone or osseous deformities, or disorders in the implant fixation area which could
impair the stability of the fixation of the joint replacement primarily or over time
■
Known hypersensitivity to the implant materials
■
Cups whose implantation, based on ISO 21535, result in a limited range of motion (less than 80° in flexion/exten-
sion or less than 60° in abduction/adduction), e.g. Bipolar cup
■
Prosthesis heads with neck length XL in combination with short stem prosthesis size 0 and 1
■
Prosthesis heads with neck length XXL
■
All areas of application not mentioned under 'Indications'
Relative contraindications
The following conditions, individual or combined, can compromise the success of the operation:
■
Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activ-
ity
■
Severe osseous deformities
■
Prevents axial misalignments
■
Disorders of bone metabolism
■
Pharmaceutical or other drug abuse; alcoholism
■
Expected lack of patient cooperation
Use of the product in these cases requires the individual, critical assessment of the doctor.
Side effects and interactions
■
Dislocation, loosening, wear, corrosion and fracture of implant components
■
Joint dislocation and postoperative changes in leg length
■
Primary and secondary infections
■
Venous thrombosis, lung embolism, 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
■
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.
■
It is the operating surgeon's responsibility to ensure the correct combination of implant components and their
implantation.
■
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 have been tested and approved in combination with Aesculap components. If other
combinations 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 tested for safety and compatibility in an MRI environ-
ment. It has not been tested for heating, movements or image artifacts in MRI
examinations. Performing an MRI scan of a patient with this implant may cause
injury to the patient.
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 gamma-sterilized.
►
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
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
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
■
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 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 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 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 ath-
letic 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 site is prepared in the following way:
►
Following a high femoral neck osteotomy, open the femur with the implant-specific awl.
►
Introduce the awl until it reaches the lateral corticalis.
Bone fractures/perforations in the implant bed will adversely affect the implant
fixation!
►
Avoid bone fractures by applying careful surgical techniques.
►
Treat bone fractures by appropriate intraoperative and postoperative thera-
WARNING
pies.
►
Handle the implant components properly.
►
Gradually prepare the implant bed with the implant-specific form rasps (starting with the smallest size).
►
Check and, if necessary, correct the implant position, depth and antetorsion.
►
Check the stem size against the form rasp that was introduced last in the correct position.
►
Attach the rasp trail adapter and perform trial reduction with the appropriate trial heads; change rasp trial
adapter or trial heads as appropriate.
►
Check the mobility/range of movement and stability of the joint and the length of the leg.
►
Remove the trial implants and the rasp.
►
Insert short stem with specific insertion instruments.
►
Select a prosthesis ball according to the trial heads.
►
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).
►
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.
►
Do not remove the protective cap until immediately before positioning the prosthesis head.
►
Attach the prosthesis ball and prosthesis cone to each other at room temperature only. If necessary, allow the
implant to cool down to room temperature.
►
Apply the prosthesis head with a slight turn under axial pressure and fix in place by hammering with a plastic
(not metal) head impactor.
►
To prevent abnormal wear and tear of the prosthesis: Remove all obvious bone cement residues and bone chips
before closing the wound.
Further information on Aesculap implant systems is available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
TA-Nr. 012200
10/16
V6
Änd.-Nr. 55127
Publicité
