Device Dossier
Symbol Cup DM CEM Cemented - Acetabular shell
Device Dossier for Symbol Cup DM CEM Cemented - Acetabular shell (Acetabular shell, Class III, sponsor Active Surgical). ARTG record, intended purpose,…
- GMDN category: Acetabular shell
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.Target population: Adult population, older than 70. Patients who are candidates for total hip arthroplasty with a very high risk of displacement, and patients who are candidates for revisionarthroplasty 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 Functional recovery, Joint function restored, Pain relief, Life-span of implants 10 years Indication for SYMBOL CUP DM CEM cups: • Destruction of the hip joint resulting from degenerative, post-traumatic or inflammatory lesion. • Hip prosthesis revision.
Functional description
The Symbol Cup DM CEM dual mobility cup is a modular acetabular implant made from CoCr. The inner surface is mirror polished. The outer surface is unpolished and presents a macro-geometry to increase the surface in contact with the cement. For cemented use.