Product complaint (b)(4).Investigation summary: the device associated with this report was received for analysis.Visual examination of the returned device confirmed, the reported event.The ceramic insert was fractured into multiple pieces.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 of each lot number were reviewed.The quality documents show, that the data obtained on the insert conformed to the specification valid at the time of production.Device history review: the component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There is no indication of any preexisting material defect.
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