DEPUY ORTHOPAEDICS INC US XTND GLENO ECC D38MM +2MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number 130762038 |
Device Problems
Difficult to Insert (1316); Off-Label Use (1494)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that the glenosphere screw would not lock into the metaglene collet.Everything was implanted and used according the the surgical technique, but when the surgeon went to tightent the screw into the metaglene it acted as if it was stripped.A good bite was not attainable and the screw would just keep spinning and not engage into the collet.Any excess bone was removed around the metaglene, so the surgeon did not see any interference with the head.The glenosphere had good fixation via the morse taper onto the metaglene, so the surgeon left it as that without tightening the screw.
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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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#130762038/lot#d21110173 combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part# 130762038/lot# d21110173 combination.
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