Catalog Number 130760142 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Code Available (3191)
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Event Date 01/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Glenosphere would not engage the metaglene.
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Manufacturer Narrative
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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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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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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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(b)(4).The device associated to the complaint were returned for analysis.The visual analysis carried out on the returned product watch a deterioration of the thread of the fixing screw of the glenosphere.The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint.A search into the complaints database was performed, no other similar complaint was reported for the affected product codes and lots combinations.Based on the information received and the investigation performed, the root cause of the incident could not be determined with certainty.The incident could have occurred during use, from an assembly not in the axis.(no product problem identified).Depuy considers the investigation closed at this time.Should the 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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