On 17 july 2017 the medical affairs director performed a clinical evaluation and commented as follows: femoral stem loosening in cementless tha less than 1 year after primary.No contact or osseointegration is visible from the pre-revision x-rays.According to report, the patient's bone quality was deemed poor, a known and reported partial contraindication to a cementless implant.Signs are radiographically visible that may be consequent to a fracture fixation implant, this may have contributed to poor bone quality, in spite of young age of the patient.We see no reason to ascribe this failure to a faulty device.Batch review performed on 19july 2017.(b)(4).
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