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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 02/07/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient, initial right shoulder implanted on an unknown date, underwent a revision procedure on (b)(6), 2024.All exactech shoulder components were removed due to infection.This included an hrp construct, humeral tray/liner, as well as reverse glenoid components.No new devices were implanted.The patient will likely be revised to exactech devices in the future.There were no device breakages or surgical delays during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as it is against hospital policy.No device images were provided.No further information.
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Search Alerts/Recalls
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