For the partial or total artificial replacement of the joints of the body such as: hip, knee, shoulder and for the treatment of complex cases, osteoarthritis, joint instability, allowing to restore mobility, correct deformities, joint reconstruction, specific clinical indications according to the articulation and model or reference. Prostheses for articular replacementMATHYS® of shoulder primary osteoarthritis, secondary osteoarthritis, rheumatoid arthritis, post-traumatic osteoarthritis, arthropathy with rotator cuff tear (hamada grade III or IV) in young patients, joint metabolic deficiency (eg, chondrocalcinosis, hemosiderosis, urate arthropathies ), sequelae of fractures (healing of humeral head fractures, healing sinussion / pseudoarthrosis, necrosis of the head, blocked dislocations), avascular necrosis of the head (if there are sufficient bones), poly-fragmentary fractures and comminution of the head of the humerus with danger of disorders in fragment vascularization, proximal humerus fractures not treatable by osteosynthesis, secondary dislocation of the fragments subsequent to osteosynthesis in the proximal humerus, rotator cuff arthropathy (RDA), revision of total prosthesis or failed semiprosthesis in patients with pathological rotator cuff, in certain tumorous modifications of the proximal humerus. MATHYS® Hip Joint Replacement Prosthesis: joint degenerative disease, such as primary or secondary coxarthritis, advanced loss of substance, and functional loss of the hip joint caused by degenerative or post-traumatic or rheumatoid osteoarthritis, avascular onecrosis fracture of the femoral head or fracture of the femoral neck, after a previous surgical intervention, after osteosynthesis, reconstruction of the joint,
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
The prosthesis system for joint replacements and its associated instruments C2F is designed for the partial or total artificial replacement of the joints of the body and indicated for the treatment of joint complexes, osteoarthritis, joint instabilities. Allowing to restore mobility, correct joint deformities, joint reconstruction, with specific clinical indications according to articulation and reference. Prostheses for hip replacement of the prosthesis system for joint replacements and their associated instruments C2F, have other indications:? In case of pain due to the articulated joint destruction resulting from degenerative, inflammatory or post-traumatic pathology, or to the resulting effects after a trauma, or to the failure of previous operations. ? For first or secondintention surgery. ? Avascular necrosis. ? Traumatic arthritis ? Degenerative inflammatory disease of the joints including rheumatoid arthritis, arthritis secondary to a variety of diseases and abnormalities, and congenital dysplasia among other indications for use, prostheses for knee replacement of the prosthesis system for joint replacements and its associated instruments c2f®, for the treatment of:? Rheumatoid arthritis ? Post-traumatic arthritis, laosteoarthritis or degenerative arthritis. ? Failed osteotomies? Advanced articular destruction resulting from degenerative, inflammatory opost-traumatic pathology? Surgery of first intention, in the primary gonarthrosis associated to: important axial deviation, important laxity or important rigidity. ? Revision surgery of knee prostheses that have been found, in particular, in the case of a second recurrence of axial deviation, abnormal laxity or severe rigidity.