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Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Joint Laxity (4526)
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Event Date 12/22/2023 |
Event Type
Injury
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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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Event Description
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It was reported via a customer satisfaction survey, that a patient, initial shoulder implanted on an unknown date, underwent a revision procedure on (b)(6) 2023.The rep indicated the revision procedure was mostly due to liner instability.No further information known.
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Search Alerts/Recalls
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