Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address pain and periprosthetic infection.Aspiration was negative for bacteria but also had 111 white blood cells.Intraoperatively, there was gross pus, bone loss, a deficiency of the posterior column related to the infection and fracture cracks in the proximal femur.Implants were removed and a non-articulating spacer construct of unknown manufacturer was placed.Revision notes on the second revision for removal of said spacer on (b)(6) 2018 indicate presence of a dark murky fluid consistent with metallosis as well as chalky, metallosis type debris.Doi: (b)(6) 2006, dor: (b)(6) 2018 (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.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.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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