The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package
insert, please contact Biomet at the contact information provided herein.
VANGUARD CR STEM HOUSING
INSTRUCTIONS FOR USE
WARNING!!: The surgeon must have a thorough knowledge of the medical, surgical and
mechanical aspects concerning the use of this product, and should read these instructions
carefully before using it.
PRODUCT DESCRIPTION
The CR Vanguard stem housing comprises a central body fixed to a Vanguard CR femoral
component by two fixing screws (included in the product packaging). The central body also has
a space for securing an intramedullary femoral stem with a fixing screw (included in the stem
packaging).
Both components (the central body and fixing screws) are made of a chrome-cobalt-molybdenum
alloy.
The Vanguard CR stem housing can only be used with CR Femoral Components of the
Vanguard Knee system and with Intramedullary Femoral Stems from the Maxim Knee
system.
INDICATIONS
Total knee arthroplasty in the following cases; osteoarthritis, traumatic arthritis, rheumatoid
arthritis, correction of functional deformities, and replacement techniques when other treatments
have failed.
CONTRAINDICATIONS
a) Absolute contraindications
1. Infection or inflammation of the knee joint.
2. Distant foci of infection that could lead to spreading to the prosthesis through the
bloodstream.
3. Rapid progression of primary or metastatic tumours, or bone metastasis, as shown by
destruction of bone mass or bone absorption that is evident in the X-ray.
4. Patients with immature skeletons.
5. Patients who are hypersensitive or allergic to any of the product components indicated on
the unit container label.
b) Conditions increasing the risk of failure
1. Uncooperative patients or those with neurological disorders, senile patients, patients with
mental illnesses, alcoholic patients or drug addicts, patients unable to follow the surgeon’s
advice.
2. Marked bone loss, severe osteoporosis or reviews for which the prosthesis cannot be
properly secured.
3. Patients with metabolic disorders that could reduce bone formation or cause bone loss.
4. Osteomalacy.
5. Pathological obesity.
6. Poor prognosis for wound healing (e.g. bedsores, terminal diabetes, serious protein deficit,
and or/ malnutrition).
WARNINGS
a)
Implant resistance and load:
Although these types of devices have a high success rate, they
cannot be expected to support the same high levels of activity, load, resistance and longevity as
those of a healthy bone. The load caused by bone support and the activity levels will determine
the prosthesis service life. It is advisable to carry out regular controls following surgery.
b)
Adequate selection of the implant:
The adequate selection of the size, shape, and design of
the prosthesis will increase its possibilities of success. The implant requires careful setting with
adequate fixation to bone.
The Vanguard CR stem housing can only be used with CR Femoral Components from the
Vanguard Knee system and with Intramedullary Femoral Stems from the Maxim Knee system.
c)
Critical factors in selecting the patients:
1. Occupation or activity: if the patient’s occupation or activity involves making efforts with the
knee, the resulting force could cause a failure in the fixing and/or implanting. The implant
will not restore function to the level of a healthy bone, and patients should not be given false
expectations.
2. Senility, mental illness or alcoholism: these conditions, among others, could cause the patient
to ignore certain limitations and precaution in using the implant, with the risk of failure or other
complications.
3. Hypersensitivity to foreign bodies: in the event of suspecting the presence of hypersensitivity
to metals, the appropriate allergy tests will be performed before placing the implant.
PRECAUTIONS
a)
Sterile, disposable product:
The product is marketed sterilized by gamma radiation. It cannot
be implanted after the expiry date shown on the label. The implant must not be re-sterilized by
the user.
Furthermore, the implant should not be reused under any circumstances, since although it may
appear to be intact, it may have minor defects, microscopic flaws or internal stress points that
could cause it to break due to fatigue or fail due to the application of direct or indirect static or
dynamic loads or other undesirable types of functioning.
b)
Handling the implant:
The implant must be handled with care, using the special instrument
designed for implanting it, otherwise faults could occur in the finish of its surface or other faults
that eventually cause the device to fail.
Should it be necessary to remove the implant, the user must treat it as biological waste and
arrange for its disposal pursuant to internal hospital procedures.
c)
Instructions and information for the patient:
The surgeon must instruct and inform the patient
regarding the limitations of the implant so that the patient can take the necessary precautions as
regards supporting weight and load, to ensure healing is complete. The patient must be warned
that failure to abide by the post-surgical instructions could lead to the implant being broken or
moving more than it should, in which case review surgery will be necessary to remove it.
Furthermore, the surgeon should advise the patient regarding the composition of the implanted
product which is describe on the unit container label, for the patient to notify this during
subsequent diagnostic tests such as magnetic resonance imaging.
d)
Surgical technique:
The implant must be used by surgeons who are very familiar with and
experienced in the surgical technique and post-surgical care of the patient. To obtain more
information, a special surgical technique is available to the surgeon.
POTENTIAL ADVERSE EVENTS
1. No consolidation or delayed consolidation.
2. Fracture, loosening or sinking of the prosthesis.
3. Sensitivity to metals or reactions to foreign bodies.
4. Loss of bone density due to the transfer of load.
5. Pain, discomfort or strange sensations due to the presence of prosthesis.
6. Injuries to the nerves, soft tissues or blood vessels caused by surgical trauma.
7. Fracture of bone structures.
8. Bone necrosis.
9. Bleeding.
10. Infection.
CAUTION:
Federal law (USA) restricts this device to sale by or on the order of a physician.
ADDITIONAL INFORMATION
For further information, please contact the nearest BIOMET representative or distributor.
