Product complaint # (b)(4).Investigation summary: examination of the returned package confirms the reported observation.The root cause could not be determined.A review of the device manufacturing records found no deviations or anomalies.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: lot 9330519.Review of the device manufacturing record found no related deviations or anomalies.Device history review: review of the device manufacturing record found no related deviations or anomalies.
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