Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of the 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: protocols and certificate of conformance were reviewed.The quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Device history review: protocols and certificate of conformance were reviewed.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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