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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 02/19/2024 |
Event Type
Injury
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Event Description
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It was reported that a male patient, initial right shoulder implanted on an unknown date, underwent a revision procedure on (b)(6) 2024.The patient was infected during the initial surgery.During this surgery, initial implants were removed, and an antibiotic spacer was then implanted.The patient was revised with a competitor¿s temporary hip spacer.There was no surgical delay or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays or device images were able to be obtained.The explanted devices were sent for cultures and are unavailable for return.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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