Revision completed due to loosening of the metaglene at the bone to implant interface.It was also reported that the 12 year old delta reverse became unstable, poly wear is present, and this is a glenoid defect.Patient converted into a cta, stem was well fixed.Doi- unknown.Dor- (b)(6) 2022.Affected side- left shoulder.
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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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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