EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number HUMERAL LINER, 40MM, +0 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Joint Dislocation (2374)
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Event Date 02/17/2023 |
Event Type
Injury
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Event Description
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It was reported via a clinical study, ¿equinoxe shoulder study¿, that a 55 yo female patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient dislocated their left shoulder anteriorly/inferiorly on (b)(6) 2023, with no injury reported, and underwent revision due to an acute inferior dislocation.The humeral liner was revised.The study indicates the event was definitely not related to the device or the procedure.The event was resolved on (b)(6) 2023.No further details.
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Manufacturer Narrative
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D10: concomitants:5.6969622 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.A280070 320-31-40 - glenosphere, 40mm.A314350 320-10-00 - equinoxe reverse tray adapter plate tray +0.A316194 320-35-01 - small glenoid plate.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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