On 23 june 2017 the medical affairs performed a clinical evaluation and commented as follows: femoral component revision surgery in a young overweight patient 7 years after primary cementless tha.No pre-revision x-ray is available.According to the report, the reason for revision was stem loosening.Aseptic loosening is a possible, literature described adverse event after tha and causes are often unknown.In this case, reason for failure can't be determined.Batch review performed on 10 july 2017.Lot 110850: (b)(4) items manufactured and released on 05 may 2011.Expiration date: 2016-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.On 12 july 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: scratches and signs can be noted on both internal and external surfaces of the ceramic head.Scratches can be noted on the neck portion of the stem.The root cause of the event cannot be determined.
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