(b)(4).Investigation summary: evaluation 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 113710000, lot number z1kfg1000.Device history review: dhr for part number 113710000 batch number z1kfg1 was reviewed.1 piece was scrapped at operation 20.No other deviations or anomalies were found.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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