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Model Number 320-32-36 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.Concomitant device(s): 306-01-08, equinoxe, humeral long stem 8mm 175mm; 320-36-03, 36mm humeral liner +2.5mm unconstrained; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-35-06, small extended cage glenoid plate.
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Event Description
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As reported, approximately 1 yr.Postop the implanted ltsa and entered this clinical study, this (b)(6) female patient who had a history of infections in prior implanted devices (manufacturers unknown) presented with aseptic glenoid loosening.Radiographs showed aseptic glenoid loosening and that the bone graft had not incorporated.The surgeon opted to do a staged revision with bone grafting of the iliac crest to the glenoid followed by a revision to a reverse tsa.The first procedure (removal of components, bone grafting, and placing antibiotic spacers) was performed on (b)(6) 2021.The conversion to a reverse tsa was performed on (b)(6) 2021.The patient was an inpatient for 2 days and discharged home.This event was reported as resolved on (b)(6) 2021.The case report form indicates this event is not related to devices and definitely related to the procedure.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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Section h10: (d4) serial number: (b)(6), expiration date: 07-may-2029, (h3) the revision reported was likely the result of both patient conditions and an insufficient bond between the glenoid baseplate and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices and x-rays were not available for evaluation.Section h11: *the following sections have corrected information: (d2b) common device name: small extended cage glenoid plate (d4) catalog number: 320-35-06, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 320-36-03 - 36mm humeral liner +2.5mm unconstrained (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).306-01-08 - equinoxe, humeral long stem 8mm 175mm (b)(6).320-32-36 - expanded glenosphere, 36mm, for small reverse (b)(6).321-20-00 - equinoxe reverse shoulder drill kit (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).
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Search Alerts/Recalls
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