EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number 320-38-00 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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(d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm: 5672589.320-01-38 - equinoxe reverse 38mm glenosphere: 5776842.320-10-00 - equinoxe reverse tray adapter plate tray +0: 5889260.320-15-01 - eq rev glenoid plate: 5798298.320-15-05 - eq rev locking screw: 5829399.320-20-00 - eq reverse torque defining screw kit: 5732716.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 5691110.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 5858345.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 5616557.320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm: 5864647.(h3) pending evaluation.
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Event Description
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As reported by the equinoxe shoulder study, the 64-year-old male patient had a right tsa on (b)(6) 2019.The patient presented with disassociation of polethylene, post operatively on (b)(6) 2021.It was reported that the patient experienced dislocation of joint and disassociation of polyethylene.This event is related to (b)(4).The outcome of this event is considered resolved by action of revision on (b)(6) 2021.The case report form indicates that this event is definitely related to the device and to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
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Search Alerts/Recalls
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