Patient Information - merete BioBall MaxiMotion Gebrauchsanweisung

with old, damaged ones. In such cases, special conditions apply:
- Both sliding partners of an artificial joint must always be replaced simultaneously.
- Only metal heads may be used with used stem tapers.
- Ceramic heads may only be used on a stem taper already in use in combination with a BioBall™ adapter.
If the stem taper is severely damaged, the prosthetic stem is to be revised.
3. Instructions for use
3.1 Sterile implants
Implants which are delivered sterile are clearly labelled "STERILE". Sterile implants have been sterilised with 25 – 42
kGy (2.5 – 4.2 Mrad) gamma rays or ETO (ethyl oxide). Until used, all sterile implants are to remain in their original
packaging, protected from light and moisture, at room temperature or in cool but frost-free environments. Before using
an implant, check the sterilisation expiration date on the product label, and check for any damage to the protective
packaging. The steri-dot on the packaging serves as an indicator that the product is sterile. Products that have been
sterilised with gamma rays are marked with an indicator (red steri-dot) on the outer packaging. Products that have
been sterilised with ETO are marked with an indicator (green steri-dot) on the primary packaging. Do not use products
in damaged packaging. Observe the rules of asepsis when removing products from their protective packaging.
3.2 Resterilisation
Merete wishes to provide patients with cutting-edge technology products at all times. As such, we do not offer product
re-sterilisation.
3.3 Storage and Handling of Implants
Store all implants in their unopened original packaging at room temperature or below (but frost-free) in a clean, dry
environment, protected from light. Before using an implant, check the sterilisation expiration date on the product label,
and make sure that the protective packaging is undamaged. Do not use products in damaged packaging. Observe the
rules of asepsis when removing products from their protective packaging. Implants must be handled with the utmost
care, as even the smallest amount of surface damage can lead to complications or implant failure. As such, do not
label or mark implant surfaces, and avoid touching them with metallic or other hard objects (e.g., instruments). Do
not touch BONIT surfaces prior to implantation. Any mechanical manipulation or alteration of joint endoprostheses
®2
is not permitted and will result in a loss of approval. Do not use implants that have been handled incorrectly or show
signs of damage (e.g. scratches – see also 3.2).

3.4 Patient information

Surgeons must make their patients aware of information mentioned in Section 2, i.e. any factors that could hinder
the success of the operation as well as potential complications that may occur as a result of specific indications.
There is a risk of the implant failing early, for example due to implant luxation, dislocation, or loosening caused by
changes in load bearing behaviour, fatigue and fracture of the cement bed, and/or tissue reactions to the implant and
its abrasion particles; see also 2.7.
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