Catalog Number L94005 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation summary: the complaint was deemed as justified.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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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The rubber ring and area behind the rubber ring in each trial neck contains dried blood when removed.This is unsterile and presents a sterility risk.The cssd department will not re-sterilise the trial necks without the rubber ring unless provided written approval from j&j to do this.All corail trial necks were examined at the hospital and all were found to have dried blood in the area behind the rubber ring, which holds the trial neck to the femoral broach.The cssd department will not continue to re-use the trial necks with rubber rings.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: the complaint was deemed as justified.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
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Search Alerts/Recalls
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