EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Dislocation (2374)
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Event Date 10/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Section d10: concomitant products: equinoxe, humeral stem primary, press fit 9mm (cat# 300-01-09 / serial# (b)(6).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).Equinoxe reverse 38mm glenosphere (cat# 320-01-38 / serial# (b)(6).Sup/post aug plate, l rs glenoid baseplate (cat# 320-15-07 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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As reported equinoxe shoulder study, approximately four months post initial left tsa, the 73 y/o female patient had a dislocation.Patient had increasing pain during exercises; dislocation with glenoid neck fracture along montage bone graft in revision rtsa.The event was resolved with closed reduction under anesthesia on (b)(6) 2020 and continue sling.Per clinical report, the reported event is unlikely related to the device but definitely related to the procedure.
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Search Alerts/Recalls
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