Catalog Number 130790036 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 03/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 patient was revised to address pain, infection,instability and loosening of the metaglene, glenosphere and the screws at bone to implant interface.Doi: (b)(6) 2014; dor: (b)(6) 2019; left shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.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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Search Alerts/Recalls
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