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

®
Aesculap
PREVISION® revision 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
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for revision operations
Modular implant components:
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Proximal component (PLASMAPORE®
µ-CaP
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Distal stem component
– PREVISION® curved
– PREVISION® straight
Materials
The materials used in the implant are listed on the packaging:
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ISOTAN® Titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
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PLASMAPORE® with calcium phosphate surface
µ-CaP
ISOTAN® and PLASMAPORE® are registered trademarks of Aesculap AG, 78532 Tuttlingen / Germany.
Indications
Use for acute disorders of the hip joint 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
Use in operations 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
The replacement of an endoprosthetic implant is a difficult intervention subject to specific conditions.
To arrive at a decision on whether to provide such replacement, the operating surgeon must assess and, if necessary,
consider the contraindications with regard to the success of the intervention.
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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Systemic diseases and metabolic disorders
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Acute osteoporosis or osteomalacia
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Severe damage to the bone structures that could prevent the stable implantation, or sufficient fixation, of the
implant components
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Non-regenerative bone conditions with lack of proximal bone support and failure of defect union
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Bone tumors in the region of implant fixation
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Bone malformations, defective axial positioning, or other bone conditions that rule out implantation of a hip-
joint prosthesis
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Expected overload on the joint implant, especially due to high patient weight or major physical strains and activ-
ities
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Dependency on pharmaceutical drugs, drug abuse, or alcoholism
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Inadequate patient compliance
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Foreign body sensitivity to the implant materials
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Prosthesis heads with neck length XXL
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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Secondary operation to remove the distal locking screws (if applicable)
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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
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Injury to blood vessels and nerves
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Hematomas and wound healing disorders
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Periarticular calcification
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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!
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It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
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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.
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The operating surgeon is responsible for combining the implant components and implanting them without bone
cement.
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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 lack of asepsis.
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The user instructions for individual Aesculap implant components must be followed.
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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.
coating) with spring nut and locking screw
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Damage to load-bearing bone structures can result in loosening or migration of the components, bone or implant
fractures, and 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.
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Delayed or failed healing of the bony implant bed can lead to implant breakage due to excessive strain on the
implant material.
Interactions between MRI and implant components!
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MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an
additional risk to implant bearers.
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MRI causes non-critical, localized heat development.
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Implants produce moderate MRI artifacts.
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A precise diagnosis requires X-rays taken in the anterior-posterior and medial-lateral directions.
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Observe material, friction coupling diameter and cone specifications.
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Observe further restrictions for combined implants.
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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.
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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.
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Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
Sterility
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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!
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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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Operating conditions are highly aseptic.
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All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
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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.
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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.
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Information has been obtained from the manufacturer in the event of an ambiguous preoperative situation and
if implants are present in the area to be treated
The implantation involves the following steps:
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Remove the hip endoprosthesis stem to be revised via a suitable access point, if necessary.
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Remove bone cement residues, granulation tissue, and, if necessary, devitalized bone parts.
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Employ a careful operating technique in order to prevent further damage to the bone.
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PREVISION® curved: To prepare the implant bed, use distal intramedullary drills and modular form rasps (with
proximal and distal components); begin the treatment distally, using the smallest intramedullary drill to start
with and getting steadily larger, and proceed with the modular form rasps.
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PREVISION® straight: To prepare the implant bed, use reamers and proximal form rasps (assembled with trial
components); begin the treatment using the smallest reamer, getting steadily larger, and proceed with the form
rasps.
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Note the depth markings on the instruments when preparing the bone.
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Select implant components (distal and proximal) according to the form rasps (PREVISION® curved) or proximal
form rasp and trial component (PREVISION® straight) last inserted in the correct position.
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Implant the distal implant components, taking note of the depth markings (orientate to the intended head center
or trochanter major, respectively).
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Carry out distal locking of the distal stem component with two locking screws, if necessary.
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Use Aesculap 5 mm locking screws for this step. Observe the instructions for use of the locking screws.
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Perform trial reduction with the proximal trial implant; check for joint mobility, stability, and leg length.
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Remove the trial implant; carefully rinse, clean, and dry the cone coupling of the distal implant.
Implant breakage or loosening of implant couplings caused by contaminated or
damaged coupling surfaces!
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Check coupling surfaces for contamination and damage.
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Introduce the proximal implant carefully and in proper axial alignment.
CAUTION
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Insert the modular proximal implant component. Make certain that the component is implanted at the correct
position (axial and rotational) and implantation depth.
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Insert the spring nut into the proximal implant and screw it on hand-tight, using the socket of the torque wrench.
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Attach the adapter rod of the counterholder to the distal implant and allow it to engage.
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Apply the torque wrench and couple the counterholder to the adapter rod.
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Fix the spring nut, making sure that the counterholder is not twisted in the process.
Insufficient coupling of the implant components due to the spring nut being
tightened too firmly or not firmly enough!
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Follow the instructions for use of the torque wrench.
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Have the torque wrench inspected by the manufacturer every 2 years.
CAUTION
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Tighten the spring nut until the torque wrench releases audibly.
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Remove the torque wrench and the counterholder.
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Screw in the locking screw.