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Model Number 320-02-42 |
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 11/18/2021 |
Event Type
Injury
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Event Description
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As reported, this (b)(6) y/o female patient was previously revised on (b)(6) 2020 for with a loose humeral component from a suspected infection.Currently, patient's stem is loose.Removed humeral components as well as glenosphere, locking screw and compression screws.Replaced all shoulder components.The patient has a bmi of 50+.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.
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Manufacturer Narrative
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Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-01-15, (b)(4) - equinoxe, humeral stem primary, press fit 15mm; 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-42-10, (b)(4) - equinoxe reverse 42mm humeral const liner +0; 320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm; 320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm.
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Manufacturer Narrative
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(h3) the revision reported was likely the result of both patient-related conditions and an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral 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: humeral stem primary, press fit 15mm (d4) catalog number: 300-01-15, serial number: (b)(6), expiration date: 10-jan-2029, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 320-10-00, 6622588 - equinoxe reverse tray adapter plate tray +0.320-15-05, 6610420 - eq rev locking screw.320-20-00, 6624065 - eq reverse torque defining screw kit.320-42-10, 6136285 - equinoxe reverse 42mm humeral const liner +0.320-20-38, 6022248 - eq rev compress screw lck cap kit, 4.5 x 38mm.320-20-38, 6044687 - eq rev compress screw lck cap kit, 4.5 x 38mm.320-02-42, 6528863 - rs expanded glenosphere 42mm, +4mm offset.(g4) pma/510(k)number: k042021.(h4) device manufacture date: 12-jan-2019.
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