Device Dossier

Symbol Cup DM HA - Acetabular shell

Device Dossier for Symbol Cup DM HA - Acetabular shell (Acetabular shell, Class III, sponsor Active Surgical). ARTG record, intended purpose, GMDN…

Intended purpose

This device is intended for permanent prosthetic replacement of the acetabular component of the hip joint, during first-line or revision total hip arthroplasty in the adult population, older than 70 in Patients who are candidates for total hip arthroplasty with a very high risk of displacement, and patients who are candidates for revision arthroplasty in cases of repeated displacement or with a high risk of displacement. Total hip replacement is intended for use in patients with a very painful joint and/or persistent disability after an observation period of several weeks following the failure of a well-conducted medical treatment. STATED CLINICAL PERFORMANCES are Functional recovery, Joint function restored, Pain relief, Life-span of implants 10 years Indications Destruction of the hip joint resulting from degenerative, post-traumatic lesion, Fracture or avascular necrosis of the femoral head 5. STATED CLINICAL PERFORMANCES • Functional recovery • Joint function restored • Pain relief • Life-span of implants 10 years 6. INDICATIONS Indication for SYMBOL CUP DM HA cups: • Destruction of the hip joint resulting from degenerative, post-traumatic lesion. • Fracture or avascular necrosis of the femoral head

Functional description

The outer portion of a two-piece acetabulum prosthesis. It is sterile, made of CoCr and has a bilayer Ti and HAP finish. Fixation is ensured by impaction. A disposable device to help with insertion comes into direct contact with the cup and enables the cup holder to be connected without touching the implant. The femoral head is then inserted into the liner. After verifying that there’s good mobility and good head retention in the liner, the assembly is inserted into the cup.

TGA Public Summary