Catalog Number UNK-HIP |
Device Problem
Disassembly (1168)
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Patient Problem
No Information (3190)
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Event Date 03/25/2014 |
Event Type
Injury
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Event Description
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The plastic liner luxated again in (b)(6) 2014.The patient was re-operated with a new revision of the acetabular component by the orthopaedics department of ostfold moss hospital on (b)(6) 2014.It became clear that the plastic liner had once again luxated out of the metal cup, and there were obvious problems with the locking mechanism for this prosthesis.
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Manufacturer Narrative
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Additional narrative: 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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Manufacturer Narrative
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The plastic liner luxated again in (b)(6) 2014.The patient was re-operated with a new revision of the acetabular component by the orthopaedics department of (b)(6).It became clear that the plastic liner had once again luxated out of the metal cup, and there were obvious problems with the locking mechanism for this prosthesis.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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Search Alerts/Recalls
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