The patient underwent a right knee revision due to pain, femoral component loosening at the bone to cement interface, and tibial tray loosening at the cement to implant interface.The surgeon noted the moderate removal of scar tissue.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2017.Dor: (b)(6) 2018; right knee.
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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).Investigation summary = > no device associated with this report was received for examination, however, photographs of the subject complaint sample were provided for review.No product contribution to the reported event was identified.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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, a follow-up medwatch will be filed as appropriate.
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