It was reported that the patient had their hip done by surgeon at beaumont royal oak hospital.Patients wound was looking inflamed, and surgeon felt the patient needed to be washed out with a head and liner exchange.When in hip, cultures were taken that confirmed infection.Hip was thoroughly washed out, a new head and liner was implanted, and the hip was reduced.Stability of the hip was confirmed, and the closing process began.There was no surgical delay doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side : left hip.
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Product complaint # (b)(4).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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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