Original M.E. Müller Durasul-PE Low Profile Cup - Polyethylene acetabulum prosthesis

Intended purpose

The Original M.E. Müller Durasul-PE Low Profile Cup is intended to reduce pain and improve hip function through cemented fixation of primary or revision total hip arthroplasty (THA) in the acetabulum of patients with an adequate bone stock to support the component. A THA construct consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or revision of previously failed hip arthroplasty. The cup can be implanted as a cemented cup alone or in combination with Cages or Rings. All Original M.E. Müller Low Profile Cups have to be used in combination with components approved by Zimmer Biomet. All Original M.E. Müller Low Profile Cups are intended for single use only. Indications: • Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. • Failed previous hip surgery, for example, where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty procedures.

Functional description

An acetabular cup intended for use in THA to replace the acetabular component of the hip joint. The cup is made of polyethylene and contains one or two radiopaque wires made of commercially pure titanium, which enable precise identification of its position on radiographic images after implantation. Depending on the patient’s pathology, the cup may be implanted as a standalone cemented component or used in combination with an acetabular cage or ring.