Model Number 130760000 |
Device Problem
Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 03/26/2022 |
Event Type
Injury
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Event Description
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It was reported that patient had a reverse shoulder for a 4 part proximal humorous fracture.The metaglene was pulled out from the glenoid due to poor bone quality.Loosening was noted at an unknown component (non cemented).The metaglene was loose.The bone quality was not good.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: left.
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Manufacturer Narrative
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Product complaint # (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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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