Product complaint # :(b)(4).Investigation summary = > no device associated with this report was received for examination.A review of device manufacturing records found no related 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 7928506.The quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.Device history review = > the quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.
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