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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/01/2022 |
Event Type
Injury
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Event Description
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On 12/1/2022, it was reported by a sales representative via email that an apex system was removed from patient due to infection.This was discovered during a total shoulder revision procedure on (b)(6) 2022.
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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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Search Alerts/Recalls
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