Catalog Number 04.01.0124 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 10 october 2023: lot 2212977: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Other devices involved: batch review performed on 10 october 2023: lot 2247046: (b)(4) items manufactured and released on 23-feb-2023.Expiration date: 2028-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 other similar reported events in the period of review, one of them is on the same implant that was not revised in a precedent surgery on the same patient.
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Event Description
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The patient had a primary shoulder surgery on (b)(6) 2023.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The cause of the dislocation is unknown.The surgeon revised the liner and the surgery was completed successfully.On (b)(6) 2023, the patient had a dislocation of the liner from the glenosphere.The surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully.
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Search Alerts/Recalls
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