Batch review performed on 12 may 2021: lot 1811811: (b)(4) items manufactured and released on 20-may-2019.Expiration date: 2024-05-05.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: few days after partial hip replacement, the bipolar head dislocated from the natural acetabulum of the patient.The surgeon decided then to transform the partial hip to a total hip and therefore the components were explanted.No reason to suspect any device deficiency as the main cause for this reoperation.
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