Catalog Number 321-42-00 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/16/2022 |
Event Type
Injury
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Event Description
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It was reported that during removal/withdrawal, the 42mm trial liner was removed from the male patient's right shoulder after trailing and some residual yellow particles were left in the patient.The yellow residual was only found on the adapter tray.The surgeon used a small forceps and fluid to remove the pieces.The surgical site was clean close up.There was no surgical delay.Patient was last known to be in stable condition following the event.Device is returning for evaluation.Revision stated in experience report was captured under 1038671-2022-00200 / case- (b)(4).
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Manufacturer Narrative
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Device evaluated by mfr: pending evaluation.
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Manufacturer Narrative
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Based on historical complaint investigations and the returned device, the damaged device reported was likely the result of numerous surgical uses in addition to coming in contacting with other surgical instrumentation during trialing and reprocessing.
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Search Alerts/Recalls
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