Catalog Number 130790036 |
Device Problems
Fracture (1260); Difficult to Advance (2920)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint (b)(4).H4- unable to determine product manufacturing date based on the provided lot number.Continued follow-up is being conducted and any additional information received will be reported.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 central screw on glenosphere broke and dislocated from implant construct.It was replaced , as well as, one of the screws and the poly.The glenosphere was dislocated from the implant construct.Glenosphere was replaced, as was one of the screws and the poly.Doi: (b)(6) 2019.Dor: november 13, 2023.Affected side: right shoulder.
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Event Description
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Additional information received: a.Please clarify, was the glenosphere fractured? no.B.Was there any suggestion by anyone indicating that there was or may be a deficiency with the dxtend screw lock d4.5x36mm? if yes, please provide details: possibly wasn't seated all the way.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:130790036, lot - 5329003 and no non-conformances / manufacturing irregularities were identified.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 manufacturing record evaluation (nc search) was performed for the finished device product code:130790036, lot - 5329003 and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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