Model Number 320-20-00 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.Concomitant device(s): 320-42-00, 6090474 - equinoxe reverse 42mm humeral liner +0; 320-10-10, 5471713 - equinoxe reverse tray adapter plate tray +10.
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Event Description
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As reported, this was a scheduled revision of a (b)(6) y/o male patient's equinox reverse shoulder.The revision was to replace the proximal humeral tray due to a loose or broken reverse torque defining screw.We found that the screw was intact and seemed to back out after the torque defining screw was broken off per the technique.
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Manufacturer Narrative
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Section h10: (h3) the revision reported was likely the result of not resecting enough bone to properly assemble the humeral tray to the humeral stem.This improper assembly of the humeral tray to the humeral stem likely did not allow the torque defining screw to be fully seated, resulting in the torque defining screw backing out and subsequently the humeral tray disassociating from the humeral stem.However, this cannot be confirmed as the explanted devices from the first revision were not returned for evaluation.
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Search Alerts/Recalls
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