[translate].The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time period, when the item was produced.On the basis of the provided pictures of the complaint sample, a fracture of the female cone of the modular shaft can be confirmed.The complaint samples were not available for examination.The first signs of loosening and first axial deviations can already be seen in the x-ray images taken in 2013.The x-rays from 2018 show a fracture in the proximal tibial prosthesis at the tapered connection to the shaft.Furthermore, an osteolysis at the transition to the femoral component is visible at the distal femur.The bmi of the patient is 45.7.According to our instructions for use, obesity is a relative contraindication.Taking these circumstances into consideration, as well as a prosthesis service life of more than 7 years, a material or manufacturing defect causing the damage is excluded.Rather, the cause of the primary loosening and secondary fracture is due to patient-related overloading of the implant components.Whether the described car accident contributed to the fracture is not comprehensible.
|