Catalog Number 244000510 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Information (3190)
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Event Date 09/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).Followup with the complainant has been conducted for the lot number, and the information is not available.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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Attachment to hudson adaptor created metal particulate during case.
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Manufacturer Narrative
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The device associated with this complaint was not returned for evaluation.Review of the device history records and/or lot specific complaint database search was not possible as the lot code required was not provided.The investigation could not verify or identify and 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 at this time.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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