Catalog Number 320-01-46 |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Joint Dislocation (2374); Patient Problem/Medical Problem (2688); No Code Available (3191)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2017.Revision of shoulder components due to instability.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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Explant date was (b)(6) 2018.
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Event Description
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It was reported on (b)(6) 2018 by the equinoxe shoulder study database that the patient describes history of at least 3-5 anterior instability events.The patient also states the subluxations that are self reduced.The patient was scheduled and will have left shoulder revision surgery.And the revision was completed on (b)(6) 2018.The case report form indicates this event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.Which also indicate the problem is resolved.
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Search Alerts/Recalls
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