Additional narrative: patient was revised to address pain and disassociation of the liner from the cup.It was also noted that the liner could have been loose due to a fall that occurred 11 months prior, however that could not be confirmed.(b)(4).Unknown acetabular cup (not removed).The devices associated with this report were not returned.Review of the device history records and/or a complaint database search was not possible as the product and lot codes required were not provided.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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