The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile, single use and is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection.
A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.