Catalog Number UNK HANDLE |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # :(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2021, the patient underwent tha with the offset handle and the cup in question.During the surgery, when the surgeon drove in the cup, the offset handle and cup could not be removed.The surgery was completed successfully and there was 20 min surgical delay.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).Mrn 1818910-2021-12314 is retracted as depuy synthes is not the legal manufacturer of the device and was submitted in error.Med watch 3500a initial report mwr-(b)(4) , mrn 1818910-2021-12314 is retracted.
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Search Alerts/Recalls
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