Contraindications; Possible Side Effects - merete BioBall MaxiMotion Gebrauchsanweisung

2.5 Contraindications

- acute or chronic infections in the hip joint or the immediate vicinity
- patients with joint diseases that may be successfully treated with another, joint-preserving treatment
- inadequate implantation site for secure fixation of the implant (e.g. insufficient bone quality that prevents bone
ingrowth or major acetabular defects)
- Any comorbidities that could pose a risk to the function or success of the implant, especially severe muscular,
nervous or vascular disorders with specific effects on the limb to be operated upon
2.6 Factors Potentially Hindering Success
- Allergies to implant materials, particularly metal (e.g., cobalt, chrome, nickel, etc.) or polyethylene
- Overweight and obesity
- Local bone tumours
- Osteoporosis or osteomalacia
- Malformations, congenital hip dislocation, severe axial displacement at the knee
- Systemic or metabolic disorders
- Alcohol or drug abuse, and
- Physical activities associated with strong shocks which could result in the implant being exposed to impacts and/
or excessive loads (e.g. hard physical labour, certain types of sport, etc.)

2.7 Possible Side Effects

The side effects listed below are among the most common negative consequences of implantation procedures:
- loosening of the implant as a result of changing load transfer conditions or cement bed fatigue and fracture, and/
or tissue reactions to the implant and its wear debris
- Implant failure or subsidence due to overloading
- Early or late infections
- Dislocation, subluxation, insufficient range of motion, undesired shortening or lengthening of the affected
extremities as a result of suboptimal implant positioning
- Bone fracture due to unilateral overloading or weakened bone substance, reduction in bone density due to
stress shielding or bone degradation as a tissue response to wear particles
- Temporary or permanent nerve damage due to pressure or haematoma
- Wound haematoma and slow wound healing
- Vascular disorders, including deep vein thrombosis, pulmonary embolism, and cardiac arrest
- Heterotopic ossifications
- Nerve damage due to surgical trauma
2.8 Preoperative Planning
Operation planning should be done on the basis of in-depth evaluations of patient X-rays, which provide the
information necessary for determining the appropriate prosthesis type, size, and possible combinations. If desired,
22