Pfs and medical records received.The patient was revised for infection on (b)(6) 2016.All implants were removed.The stem and femoral head are competitor products.There was a 1800ml blood loss noted during the (b)(6) 2016 revision, with no indication of the cause.At this time there is no infection alleged per the litigation.**it should be noted that the stem and head were revised on (b)(6) 2016 for a fractured stem ((b)(4))** update ad 8 aug 2018: ppf and implant records and sticker sheet records received.In addition to what were previously alleged, ppf alleges abductor muscle repair.Doi: (b)(6) 2009(cup), (b)(6) 2013(liner) - dor: (b)(6) 2016 (right hip).
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: 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 medwatch, a follow-up medwatch will be filed as appropriate.
|