Product complaint # (b)(4).Investigation summary: examination of the returned packaged stem confirms the reported observation.The root cause for the damage is suspected to be from distribution or inadvertent user handling.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.Device history lot: based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to the packaging process contained in the manufacturing records that would contribute to the reported event.Records review not performed.
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