This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4), if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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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.
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