Additional information received on 15 march 2017 and includes: the surgeon revised all medacta product on 14 march 2017 and the surgery was completed successfully.On 17 march 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision of cup, head and liner occurred 3 years after primary tha in a grossly overweight (as visible in the images) patient.Radiographic images show the migration of the cup across the medial wall.On the femoral side, signs of stress shielding can be observed.The resection level of the femur is rather low; the reasons for this choice are not known but this can have contributed to make the fixation of this stem more difficult, given also the patient's weight.Postoperative images are not available, so the initial cup position and acetabular preparation cannot be assessed.There are no indications of a defective device being the responsible agent for this failure.Batch review performed on 05 april 2017.(b)(4).
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