Revision completed due to stem sticking out of the posterior aspect of the humerus.Surgeon had to remove head, stem, and adapter and went with a longer unite stem and head in order to bridge the gap.Surgeon chose to keep the existing glenoid, only revised humeral components.Doi: unknown, dor: (b)(6) 2022, affected side: right 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 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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