Radial Head Prosthesis - ChM STERILE VH202 Instrucciones De Utilizacion

STERILE VH202
STERILE R
CEMENTED
1 PURPOSE AND INDICATIONS
1. Radial head prosthesis allows for treatment of multifragmentary fractures
of radial head when the fragments reposition and their stable osteosyn-
thesis are not possible.
1) The radial head arthroplasty is indicated in the case of multifragmentary
fractures of radial head with coexistent injuries:
a) Dislocation of elbow joint with radial head fracture.
b) Collateral medial ligament injury.
c) Collateral lateral elbow ligament injury.
d) Monteggia injury with olecranon fracture and radial head fracture.
e) Fractures of a bigger part of coronoid process.
f) Coexistent injury of distal radioulnar joint.
g) Combination of the above-mentioned – complex injury and instability.
2. For the implantation of the aforementioned products, ChM's specialist
instrument sets are dedicated. Along with the instrument set, illustrated
surgical technique is also provided. Surgical technique is not a detailed
instruction of conduct. This is the physician that determines the proper
technique and detailed surgical procedure for a particular patient.
2 CONTRAINDICATIONS
1. Contraindications may be relative or absolute. The choice of particular de-
vice must be carefully considered in terms of patient' s overall condition.
Conditions listed below may preclude or reduce the chance of successful
outcome:
1) Infection local to the operative site.
2) Signs of local inflammation.
3) Fever or leukocytosis.
4) Pregnancy.
5) Neuromuscular disorders which can create unacceptable risk of fixation
failure or complications in postoperative care.
6) Any other condition which would preclude the potential benefit
of implant application and may disturb the normal process of bone
remodeling, e.g. the presence of tumours or congenital abnormalities,
fracture local to the operating site, elevation of sedimentation rate un-
explained by other diseases, elevation of white blood cells (WBC) count,
or a marked left shift in the WBC differential count.
7) Suspected or documented allergy or intolerance to implant materials.
Surgeon shall find out if the patient develops allergic reaction to the ma-
terial of the implant (content of the implant material is presented in IM-
PLANT MATERIAL).
8) Any case not needing a surgical intervention.
9) Any case not described in the indications.
10) Any patient unwilling to cooperate with postoperative instructions;
mental illness, a condition of senility or substance abuse may cause
the patient to ignore certain necessary limitations and precautions
INSTRUCTIONS FOR USE
Important product information for

RADIAL HEAD PROSTHESIS

Product sterilized by hydrogen peroxide
(solid head of the prosthesis)
Product sterilized by radiation
(stem and modular head of the prosthesis)
Implant intended to be used with bone cement
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