On (b)(6) 2016 the (b)(6) performed a clinical evaluation and commented as follows: stem revision in tha less than two years after primary in a very tall and rather heavy patient.In the postoperative image, the stem does not seem to fill well the proximal femur, the reasons for this are unknown.Signs of proximal loosening are visible in the pre-revision x-ray.Also the screw protruding in the abdomen may be an additional source of pain, or it may be completely silent and harmless.There is no reason to suspect that the femoral loosening was caused by a faulty device.Batch review performed on 20 may 2016.Lot 132646: (b)(4) items manufactured and released on 08 august 2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 23 may 2016 the r&d project manager visually inspected the retrieved explant with the following comments: observing the femoral stem no particular sign can be noted, except on the neck: such signs were probably caused during the removal phase.Bone is present in the anterior and posterior surface of the stem, mainly on the distal part.It is not possible from the inspection of the implants determine the root cause of the event.
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