Catalog Number 130790036 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 05/28/2019 |
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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Patient was revised to address fall and loosening of the metaglene at cement to implant interface.It was also reported that patient likely broke 2 screws from the fall.Surgeon decided to revise patient shoulder and removed the glenospheres, the metaglene base plate, 4 screws, and the humeral cup.The glenoid was filled with bone graft and a delta cta head was implanted onto stem.Doi: (b)(6) 2012; 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.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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