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Mathys European Orthopaedics releases field safety notice
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Mathys European Orthopaedics released an urgent field safety notice stating the size determination table for the balanSys Knee System is incorrect.
According to the notice, the incorrect size determination table in surgical technique indicates the femoral component size C is compatible with a tibial inlay/tibial plateau size 67. However, tibial components size 67 may be correctly used only with the smaller femoral components sizes A or B. Implantation of femoral component size C may lead to an immediate risk that the knee cannot be optimally equilibrated, leading to pain and instability, as well as a risk of increased wear of the polyethylene.
Mathys recommends physicians who used the balanSys knee system review patient records and notify the local Mathys agency of any medical symptoms that may have been caused by the incompatibility. Mathys will develop and make available specific after-care measures in cooperation with its medical advisor.