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Device Problem
Output Problem (3005)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2022, it was reported through the surgical outcome system that a revision surgery is required due to a complication and motion loss.No additional information provided.Additional information requested.Additional information provided 1/11/2022: the date of the primary procedure was (b)(6) 2021 for a left shoulder arthroplasty.The complication was reported on (b)(6) 2021.Revision procedure is scheduled for (b)(6) 2022.
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Search Alerts/Recalls
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