Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patients underlying condition.Concomitant device(s): 320-15-01, (b)(4), eq rev glenoid plate, 320-20-34, (b)(4), eq rev compress screw lck cap kit, 4.5 x 34mm, 320-20-34, (b)(4), eq rev compress screw lck cap kit, 4.5 x 34mm, 300-01-09, (b)(4), equinoxe, humeral stem primary, press fit 9mm, 320-10-00, (b)(4), equinoxe reverse tray adapter plate tray +0, 320-15-05, (b)(4), eq rev locking screw, 320-01-42, (b)(4), equinoxe reverse 42mm glenosphere, 320-20-26, (b)(4), eq rev compress screw lck cap kit, 4.5 x 26mm, 320-20-18, (b)(4), eq rev compress screw lck cap kit, 4.5 x 18mm, 320-20-00, (b)(4), eq reverse torque defining screw kit.
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