Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: details for gentamicin component of combination product: dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, and strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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