Ppf and medical records received.Ppf alleges stroke, heart attack and elevated metal ions.After review of medical records, for mdr reportability, there is no revision reported.Doi: (b)(6) 2016; dor: not reported; (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).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.Update 16-jan-2019: investigation re-opened upon review of medical records.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Device history lot = null.Device history batch = null.Device history review = null.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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