Patient being revised due to infection.This is her 2nd revision on this hip.All components were explanted and a prostalac stem nd cup with a 32mm head were implanted.It should be noted that this patient already had a revision on (b)(6) 2020 for dissociation of her acetabular liner (please reference previous der for more information).No further patient information available.Doi: (b)(6) 2018, (cup).Doi: (b)(6) 2020, (head and liner).Dor: (b)(6) 2020; right hip.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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