Catalog Number 130760038 |
Device Problems
Fracture (1260); Separation Problem (4043)
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Patient Problems
Fall (1848); No Code Available (3191)
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Event Date 11/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the devices confirmed the screw had broken.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.Device history lot: the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.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 experienced an epileptic fit and fell off a horse causing the glenosphere to dissociated from the metaglene and snap the central pin of the glenosphere.In order to revise, had to replace all glenoid components.
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Manufacturer Narrative
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(b)(4).Investigation summary: examination of the devices confirmed the screw had broken.Depuy synthes considers the investigation closed at this time.Device history lot: the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.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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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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Search Alerts/Recalls
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