Batch review performed on 03 january 2019: lot 123424: (b)(4) items manufactured and released on 14 november 2012.Expiration date: 2017-10-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on january 03, 2018, 5.5 years after primary cementless dm tha the surgeon suspects pe wear.We have no report of clinical symptoms.The xray provided does not show major signs of wear or of wear effects, although there are signs of reduced bone density in some areas around the stem, but we have no clinical history and no reports of a painful hip.The ct images of the cup do not allow to infer the presence of macroscopic wear.In our opinion, revision should not be undertaken on the basis of an unsupported assumption of wear unless there is evidence of clinical symptoms.
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