(b)(4).Investigation summary = > examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > product code 129456131, lot number 167812 device history review = > review of the device history records did not reveal any related manufacturing deviations or anomalies.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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