Depuy Synthes Corail AMT Bedienungsanleitung Seite 5

ENGLISH
This IFU is not applicable for Corail AMT stem size 6
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
CORAIL AMT HA (HYDROXYAPATITE) COATED DEVICE DESCRIPTION
Corail AMT HA coated stems are manufactured of titanium alloy.
TOTAL HIP PROSTHESIS
A Total Hip Prosthesis involves the use of an individually packaged metal femoral hip stem, a modular
metal or ceramic femoral head, and either a one piece or a metal-backed two piece acetabular
component. These two piece acetabular components are comprised of a metal shell which is
assembled with either an Ultra High Molecular Weight Polyethylene (UHMWPE), ceramic* or metal**
liner. The femoral head and acetabular components are designed to replace the natural articular
surface of the hip joint.
PARTIAL HIP PROSTHESIS
Partial hip replacement or hip hemiarthroplasty using a Partial Hip Prosthesis involves:
• either the use of an individually packaged metal femoral hip stem and a modular unipolar metallic
femoral head
• or the use of an individually packaged metal femoral hip stem and a modular bipolar head
construct.
CAUTION: * Devices used in ceramic-on-ceramic applications have additional full prescribing
information that must be reviewed prior to use.
** In the USA and Canada, ceramic heads are not approved for use with metal
liners.
INTENDED USE
Corail AMT HA coated stems are intended for use in total and partial hip arthroplasty. The stems are
intended only for uncemented use.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound
bone to seat and support the components.
Partial hip arthroplasty (hip hemiarthroplasty) is intended to provide increased patient mobility
and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence
of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.
INDICATIONS
HA coated stems of the Corail Hip System are indicated for cementless use only.
TOTAL HIP REPLACEMENT
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis,
or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
PARTIAL HIP REPLACEMENT (HEMIARTHROPLASTY)
Partial hip replacement is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with
internal fixation.
INSTRUCTIONS FOR USE
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