Patient was revised to address loosening of the metaglene component at bone to implant interface.One of the metaglene screws was broken.It had been revised once before, from the original surgery on (b)(6) 2016.Surgeon removed the glenosphere, metaglene and screws.He left the broken part of the screw in the glenoid.He re-reamed the glenoid, changed the positioning of the metaglene, went up to a 42 glenosphere, used an eccentric head, put 4 new screws in, and used a +9 spacer and a 42 +3 cup.Doi: (b)(6) 2016, dor: (b)(6) 2019, left shoulder.
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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 will be filed as appropriate.
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