Batch review performed on (b)(6) 2018: lot 166469: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-01-22.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 (b)(6) 2018: hip revision surgery occurred 9 months after primary cementless total hip arthroplasty in a (b)(6) kg patient.Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown.In this case, the stem failed to find initial stability, for reasons that remain unknown.
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Visual inspection performed by r&d product manager on 28 march 2018 the collared stem appeared with a coating still present in the proximal area of the shaft, while some bone tissue were found in the macrostructures, especially in the distal part.A small groove were noticed on the neck, just under the taper.The ceramic ball head had some signs, probably occurred during the extraction.From the received parts it was not possible to determine the root cause of the event.
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