Catalog Number 04.01.0122 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Joint Laxity (4526)
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Event Date 03/19/2024 |
Event Type
Injury
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Event Description
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At about 1 month ater the primary, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause of the dislocation is unknown.The surgeon revised the liner and the surgery was completed successfully.
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Manufacturer Narrative
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Batch review performed on 11 april 2024: lot 2307537: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved.Batch review performed on 11 april 2024.Reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 2317716: (b)(4) items manufactured and released on 05-dec-2023.Expiration date: 2028-11-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
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Manufacturer Narrative
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Company g1: modified from medacta international to medacta usa.The event happened in the usa.
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Search Alerts/Recalls
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