Corail - Prescribing Information

Corail AMT Hip

Important:

This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

Indications

The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for pressfit (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. 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, or total hip replacement.

5. Certain cases of ankylosis.

The non-porous Corail AMT Hip Stem is indicated for cementless use only.

Contraindications

The following conditions are contraindications for total or hemi-hip replacement:

1. Active local of systemic infection.

2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.

3. Poor bone quality, such as osteoporosis, where, in the surgeon’s opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).

4. Charcot’s or Paget’s disease.

5. For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli, that would preclude the use of the natural acetabulum as an appropriate articular surface for the hemi-hip prosthesis.

Warnings and Precautions

HA coated implants must not be implanted with cement

Stainless steel 316L/CoCr couplings are forbidden

When changing the head on a femoral stem which is still in place, it is essential to use a metal head.

Adverse Events

The following are the most frequent adverse events after hip arthroplasty: prosthesis working loose, dislocation, infection, thrombosis, cardio-vascular disturbances, and hematoma.