B.Braun PREVISION Aesculap Orthopaedics Mode D'emploi page 2

PREVISION® revision hip prosthesis
Intended use ® revision hip prosthesis
The implant is used
• as a component of a human hip endoprosthesis: Hip endoprosthesis stem
• to combine with Aesculap hip endoprosthesis components
• for implantation without bone cement
• for revision operations
Modular implant components:
• Proximal component (PLASMAPORE® ) with spring nut and locking
µ-CaP
screw
• Distal stem component
– PREVISION® curved
- or -
– PREVISION® straight
Materials
The materials used in the implant are listed on the packaging:
Materials
ISOTAN® titanium forged alloy Ti6Al4V according to ISO 5832-3
F
PLASMAPORE® surface layer made of pure titanium acc. to
µ-CaP
ISO 5832-2, with an additional calcium phosphate coating
ISOTAN® and PLASMAPORE® are registered trademarks of Aesculap AG,
78532 Tuttlingen / Germany.
Indications
Use in revision surgery to replace hip endoprosthesis shafts:
• Cement-free revision operations
• Periprosthetic fractures
• Subprosthetic fractures
• Treatment of large bone defects on the proximal femur
Contraindications
The replacement of an endoprosthetic implant is a difficult intervention sub-
ject to individual conditions.
To arrive at a decision on whether to provide such replacement, the operating
surgeon must assess and, if necessary, weigh the contraindications with
regard to the success of the intervention.
Do not use in the presence of:
• 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
• Severe damage to the bone structures that could prevent the stable
implantation, or a sufficient fixation, of the implant components
• Non-regenerative bone conditions with lack of proximal bone support
and failure of defect union
• Bone tumors in the region of implant fixation
• Anticipated excessive load on the joint implant
• Anticipated excessive load on the joint implant, especially due to high
patient weight or heavy physical strains and activities
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
• Prosthesis heads with neck length XXL
Side-effects and adverse interactions
• Changes in position, loosening, wear and tear on, or fracture of implant
components
• Secondary operation to remove the distal locking screw (if applicable)
• 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
Note
There are no known side effects or interactions in connection with standard
MRI scans up to 3 tesla.
Safety notes
• The implant components were tested and approved in combination with
Aesculap components. If other combinations are used, the responsibility
for such action lies with the operating surgeon.
• It is the operating surgeon's responsibility to ensure that the surgical pro-
cedure is performed properly.
• 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 tech-
niques.
• The operating surgeon is responsible for combining the implant compo-
nents and implanting them 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 erroneous
indication, wrong choice of implant, incorrect combination of implant
components and operating technique, the limitations of the treatment
method, or inadequate asepsis.
• The instructions for use of the respective Aesculap implant components
must be observed.
• Only combine Aesculap modular implant components with each other.
• Do not use damaged or surgically excised components under any circum-
stances.
• Implants that have been used before must not be reused.
• The operating surgeon is responsible for combining and implanting the
implant components, with or without bone cement.
• Delayed or failed healing of the bony implant bed can lead to implant
breakage due to excessive strain on the implant material.
• 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 train-
ing, it is of particular importance that the physician keeps the patient well
informed.
• Damage to load-transferring bone structures can result in loosening of
the components, bone or implant fractures or other severe complications.
• To ensure the earliest possible detection of such catalysts of implant dys-
function, the prosthetic joint must be checked periodically, using appro-
priate techniques.
• A precise diagnosis requires x-rays taken in the directions anterior-pos-
terior and medial-lateral.
• Damage to the load-bearing structures of the implant may result in loos-
ening of components, their dislocation and migration, and other severe
complications.
• 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 com-
bination with implant components from other
manufacturers!
Use Aesculap implant components only.
CAUTION
Sterility
• The implant components come individually packed in protective packag-
ing that is labeled according to its contents.
• The implant components have been 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
expiry date or whose packaging is damaged.
Damage to implants caused by processing and
resterilization!
Do not process or resterilize the implants.
WARNING
Application
The operating surgeon shall devise an operation plan that specifies and accu-
rately 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
• Implantation instruments, including the dedicated Aesculap implant sys-
tem instruments, must be complete and in working condition
• The operating surgeon and operating room team are thoroughly conver-
sant 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 prac-
tice, the current state of scientific knowledge, and the contents of rele-
vant 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 intervention has been explained to the patient and their agree-
ment concerning the following information has been recorded:
• The revision of a hip endoprosthesis stem is a complex joint-replacement
operation; it is generally inferior to the primary joint replacement.
• 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 athletic activities.
• More revision 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 pros-
thetic joint at regular intervals.
• Where distal locking screws have been used, a second operation to
remove the metal parts is necessary.
• The patient must be informed of the limits to the allowable strain on the
implant, and be given appropriate behavior guidelines. The risks of trans-
gressing these rules must be explained to the patient.
The implantation involves the following steps:
Remove, via a suitable access, the hip endoprosthesis stem to be revised.
Remove bone cement residues, granulation tissue and, if necessary, avital
bone parts.
A careful operating technique helps preventing further damage to the
bone.
PREVISION® curved:
To prepare the implant bed, use distal intramedullary drills and modular
shaping rasps (with proximal and distal components), starting from distal
with the marrow cavity drills and proceeding with the modular shaping
rasps.
PREVISION® straight:
To prepare the implant bed, use reamers and proximal shaping rasps
(assembled with trial components), starting the preparation with the
reamers and proceeding with the shaping rasps.
Note the depth markings on the instruments when preparing the bone.
Select implant components (distal and proximal) according to the shaping
rasps last inserted in the correct position (PREVISION® curved) or to the
proximal shaping rasp with the trial component (PREVISION® straight).
Implant the distal implant components, taking note of the depth mark-
ings (orientate to the intended head center or trochanter major, respec-
tively).
Carry out distal locking with two locking screws, if necessary.
Use Aesculap 5-mm locking screws for this step. Observe the instructions
for use of the locking screws.
Perform test reposition with the proximal test implant; check for joint
mobility, stability and leg length.
Remove the test implant; carefully rinse, clean and dry the cone coupling
of the distal implant.
Implant breakage or loosening of implant cou-
plings caused by contaminated or damaged cou-
pling surfaces!
Check coupling surfaces for cleanness and
CAUTION damage.
Introduce the proximal implant carefully and
in proper axial alignment.
Insert the modular proximal implant component. Make certain the com-
ponent is implanted at the correct position (axial and rotational) and
implantation depth.
Insert the spring nut into the proximal implant and screw it on hand-
tight, using the socket of the torque wrench.
Attach the adapter rod of the counterholder to the distal implant and
allow it to engage.
Apply the torque wrench and couple the counterholder to the adapter rod.
Fixate the spring nut, making sure the counterholder is not twisted in the
process.
Insufficient coupling of the implant components
due to the spring nut tightened too firmly or not
firmly enough!
Adhere to the application instructions for
the torque wrench.
CAUTION
Have the torque wrench inspected by the
manufacturer every 2 years.
Tighten the spring nut until the torque wrench engages audibly.
Remove the torque wrench and the counterholder.
Screw in the locking screw.
Notes on alternative application techniques
For the transfemoral approach, the following points must be observed:
• Proximal bone portions must remain connected to the soft tissue.
• Usually, only distal intramedullary drills (PREVISION® curved) or distal
reamers are used for this approach.
• Distal implant components must be locked in position.
• The distal fixation length must exceed 10 cm.
When assembling the implant outside the bone, the following points have to
be noted:
• The sizes of the implant components are selected as in the procedure
described above.
• The rotational position of the proximal implant is adjusted analog to the
in-vivo position of the shaping rasp (PREVISION® curved).
• The procedure for mounting the implant components and using the
torque wrench remain unchanged.
• Insert the implant with the insertion tool.
After implantation, apply the torque wrench again to check that the
implant components are properly tightened.
Carry out another test reduction, checking the joint mobility, the joint
stability and the leg length.
Inspect and document the implant position during the operation (using
an image converter).
Remove the protective cap of the prosthesis cone only immediately before
installing the cone.
Rinse, clean and dry the outside cone of the stem and, if necessary, the
inside cone of the prosthesis spheres.
Install the prosthesis head.
Check that the cone size of the prosthesis head in use corresponds to the
cone plug-in connector of the prosthesis stem (cone size 12/14).
Couple the prosthesis head and cone at room temperature only.
If necessary, allow the implant to cool to room temperature.
In order to forestall abnormal wear and tear on the prosthesis: Remove all
open bone and, if necessary, bone cement residues 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.: 010988 02/11 Änd.-Nr.: 40983