Catalog Number 121887652 |
Device Problems
Fracture (1260); Material Fragmentation (1261); Malposition of Device (2616); Noise, Audible (3273)
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Patient Problems
Pain (1994); Injury (2348); No Code Available (3191)
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Event Date 03/10/2017 |
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.(b)(4).
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Event Description
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Patient was revised to address pain and a ceramic liner fracture.
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Manufacturer Narrative
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This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Event Description
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Update apr 18, 2017.Medical records received.Patient was revised to address grinding noise in the hip.Added the femoral head on the product.On the operative note it was stated that the head was scored but it was intact also, the liner was fractured in multiple planes.In addition, c-arm does confirmed there are some additional small fragments that are more inferior.All fragments and shards were removed.This complaint was updated on apr 26, 2017.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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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Event Description
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Litigation records and sticker sheets received.In addition to what was previously alleged, it was stated that the patient experienced difficulty sleeping due to pain and injury.It was also stated that the surgeon was unable to retrieve all the broken ceramic liner shards.Doi: (b)(6) 2016 - dor: (b)(6) 2017 (right hip).
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Manufacturer Narrative
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Investigation summary: the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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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Product complaint # (b)(4).Investigation summary : the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: h6 (patient).No code available is used to capture surgical interventiona nd surgery prolonged.
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Search Alerts/Recalls
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