Product complaint # (b)(4).Component code: appropriate term/code not available (g07002) used to capture no findings available.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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It was reported that this patient had his right hip replaced on (b)(6) 2023 at orthopedic surgical institute where he received a summit pinnacle construct.He began to experience some discomfort and drainage coming from his wound a few weeks after surgery.The patient was brought in for an i&d and immediate exchange of all components.The summit stem, hip ball, pinnacle cup, and pinnacle liner were all explanted.The wound was thoroughly debrided and new components were implanted.There was no surgical delay.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: right hip.
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