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.H10 additional narrative: added: a2, d1, d2, d4 (catalog, lot, udi), d10 and h4.Corrected: d3, g2, h3 and h6 (device code).Patient code "inadequate osteointegration" is being retracted as the loosening was at the cement to implant interface.Product complaint # (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.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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