AQ Implants REVISIO RTM Gebrauchsanweisung Seite 12

prosthesis, improper fixation, positioning or use despite of contraindication, can lead to early
failure due to loosening, fracture, or wear.
Typical adverse effects of artificial joints may include:
• Implant loosening or displacement and wear
• Dislocation or loosening and fracture of components
• Infection
• Impingement
• Change of limb length
• Periarticular calcification
• Heterotopic ossification
• Hypersensitivity to alloy components
• Periprosthetic fractures
• Chronic pain
• Pulmonary embolism and venous thrombosis
• Nerve damage, wound healing disorder, and haematoma
• Cardiovascular disorders
• Limited joint function and mobility
• Limited joint loading and joint pain
• Changes of the bone tissue (atrophy, necrosis)
8. Patient information
Serial or batch number as well as item number of the implanted prosthesis should be docu-
mented in the patient's record and the implant pass the patient receives after surgery. Labels are
included in the sterile packaged implants.
The patient must be informed about potential benefits and risks of the procedure and the ex-
pected effects resulting from individual physiological conditions, e.g. bone quality.
The patient must be informed about the proper handling of the implant and avoidance of harmful
activities that might lead to implant loosening or fatigue as well as bone fractures. The pati-
ent should also be informed that the degree of motion prescribed during the informed consent
discussion must be observed. Moreover, the patient should be informed that sports activities
are possible to a limited extend and after consultation and individual risk assessment by the
attending physician.
Patient information should also include the possible need for partial or total revision surgery, e.g.
due to implant loosening as a consequence of mechanical wear or infection.
The patient must be informed that the body weight plays a decisive role in joint replacement and
that heavy loads should be avoided.
However, the patient must be informed that regular physiotherapy should be carried out in ac-
cordance with the individual instructions of the attending physician.
The patient must be informed that diagnostic or follow-up magnetic resonance imaging (MRI)
can cause interactions with the implant.
The patient should be informed that the use of cups or asymmetrical cup inlays can result in a
limited range of motion (ROM).
Finally, the patient should be advises in which circumstances the attending physician should
be contacted.
9. Implant materials
Depending on the individual indication, joint replacement components are implanted with our
without bone cement (PMMA). The following implant materials are used:
• Cobalt alloy (CoCrMo) manufactured according to ISO 5832-4 or ISO 5832-12, respectively
• UHMWPE – Ultra-high molecular weight polyethylene according to ISO 5834-1, -2
• Calcium phosphate (CaP) coatings
• Titanium-Niobium [TiNb] or TiNb-ON coating of CoCrMo components for patients suffering
from allergic reactions to nickel, cobalt, chromium, molybdenum
• Titanium alloy (TiAI6V4), produced according to ISO 5832-3
Note:
Please follow the instructions regarding the mechanical compatibility of the implant materials
and consider potential allergic reactions to one or multiple components of these implant mate-
rials (see Contraindications).
10. Clinical follow-up
Patients with an artificial joint require continuous follow-up by the surgeon or another competent
physician. In the event of an unforeseen early implant loosening, material weakening or similar
signs of potential complications, appropriate measures can be taken in time. If a revision proce-
dure should become necessary, the chances for success are significantly higher in case of early
identification, especially if the patient's bone quality at the implant-bone interface has not yet