6
C. POTENTIAL COMPLICATIONS AND ADVERSE REACTIONS
In any surgical procedure, the potential for complications exists. The risks and
complications with these implants include:
•
Infection or painful, swollen or inflamed implant site
•
Fracture of the implant
•
Loosening or dislocation of the implant requiring revision surgery
•
Bone resorption or over-production
•
Allergic reaction(s) to implant material(s)
•
Untoward histological responses posibly involving macrophages and/or fibroblasts
•
Migration of particle wear debris possibly resulting in a bodily response
•
Embolism
See Section II for specific product information.
D. PRECAUTIONS
Following the instructions for use provided in product literature can minimize the potential
for complications or adverse reactions with any implant.
It is the responsibility of each surgeon using implants to consider the clinical and
medical status of each patient and to be knowledgeable about all aspects of implant
procedure and the potential complications that may occur. The benefits derived from
implant surgery may not meet the patient’s expectations or may deteriorate with
time, necessitating revision surgery to replace the implant or to carry out alternative
procedures. Revision surgeries with implants are common. The patient’s mental status
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