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Model Number 320-31-36 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/11/2021 |
Event Type
Injury
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Event Description
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As reported, this (b)(6) y/o female patient presented with right shoulder pain.A revision was scheduled.The surgeon removed the humeral tray, liner and glenosphere.He replaced them with a 40+4 glenosphere, neutral liner and a +10 humeral tray.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): 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0 liner.
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Manufacturer Narrative
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Section h10: h3: 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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
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Search Alerts/Recalls
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