It was reported that a patient underwent a revision procedure approximately 2.5 years post implantation due to liner disassociation.During the procedure, scapular notching was noted as well as a deformed liner locking mechanism.The poly liner, spacer, and glenosphere were exchanged.Attempts have been made and additional information on the reported event is unavailable at this time.
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(b)(4).Concomitant medical products: 40mm poly liner + 3mm 65deg, cat# 00434906603, lot# 64374987.12mm humeral stem spacer, cat# 00434903912, lot# 62952482.40mm glenosphere cat# 00434904011, lot# 64503726.Report source: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 03571, 0001822565 - 2022 - 03572, 0001822565 - 2023 - 00380.
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