Catalog Number UNK SHOULDER NON-LOCKING SCREW |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 10/29/2019 |
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 due to loosening of the metaglene.It was also reported that during the revision, the surgeon indicated that the allograft had become dislodged and did not heal.The metaglene, 4 screws, and the glenosphere were explanted and a cta head was implanted to make the construct.Non-cemented system was used.Doi: (b)(6) 2018; dor: (b)(6) 2019; right shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > the device associated with the reported event was not returned to the investigation site for evaluation.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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