English; Special Instructions - merete BioBall MaxiMotion Gebrauchsanweisung

English

1. General instructions
Prior to using Merete products, surgeons and assisting staff are to study the safety information and product-
specific guidelines listed in this product information sheet (surgical technique) in detail. The relevant documentation
is available from Merete on request. Surgeons must also be aware of any remaining risks associated with the
products he or she intends to use, and must inform patients of such risks in advance. Implant operations must
only be performed by surgeons who are not only qualified to carry out such operations, but also have extensive
proven knowledge of, and experience in, this field. The surgeon bears all responsibility for negative consequences
or complications arising from misdiagnosis, improper surgical technique, incorrect implant selection or handling, or
failure to observe the safety instructions provided in this product information sheet. Neither the manufacturers nor
authorised Merete product representatives may be held liable in such cases. Before performing operations, study the
techniques outlined in the manual carefully.
2. Basics

2.1 Special instructions

The patient must be informed about alternative treatment methods and equivalent systems for the same indication.
Hip implants are individual components within a system. As such, surgeons must take particular care to ensure
that all system components are compatible and used as intended. They may only be used in combination with
other Merete products belonging to the same system (see 3.5). For further information, consult the catalogues and
operations instructions for the products in question. In case of doubt, contact your sales representative or the Merete
GmbH Customer Care/Sales team prior to operating. Implantations must be performed using the appropriate Merete
instruments. The use of Merete instruments for purposes other than those intended is not permitted. Under no
circumstances are explanted components to be reused. Products which are supplied sterile may not be resterilised.
For exceptions, see 3.3. Additional information is available from Merete on request. There are no known interactions
with any medications.
2.2 General information on artificial joint replacement
- The use of joint endoprostheses should only be considered if, upon careful assessment, they appear to
represent a better solution than other surgical alternatives.
- Replacing a severely malformed, unhealthy joint with a prosthetic one can alleviate pain and help patients
achieve good mobility and strength. However, artificial joint implants can never replace the full functionality of
a natural, healthy joint.
- Even in artificial joints that are implanted stably, a variety of factors can lead to loosening or wear over the long
term. This can result in a need for revision surgery, which is associated with serious health risks.
- Severe morphological changes in the supporting bone structure can affect implant performance, as can wear
and tear on the prosthetic implant.
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