Model Number 320-42-00 |
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 12/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-15-01, eq rev glenoid plate; 320-01-42, equinoxe reverse 42mm glenosphere.
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Event Description
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As reported, approximately 1.5 years post op initial rtsa, this (b)(6) y/o patient was revised due to instability.Patient had been experiencing episodes of instability and increased resting pain.The case report form indicates this event is possibly 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: (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 instability 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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