DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN DEPUY POLY ACETABULAR LINER; HIP ACETABULAR INSERT/LINER
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Catalog Number UNK-HIP |
Device Problems
Break (1069); Noise, Audible (3273)
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Patient Problem
No Information (3190)
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Event Date 03/26/2014 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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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Event Description
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Patient was revised to address squeaking, disassociation of the liner from the cup, and vertical malpositioning of the cup.
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Manufacturer Narrative
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Patient was revised to address squeaking, disassociation of the liner from the cup, and vertical malpositioning of the cup.(b)(6).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.
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