Catalog Number 113643026 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559)
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Event Date 02/28/2024 |
Event Type
Injury
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Event Description
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Revision of total shoulder replacement - converted to reverse shoulder due to rotator cuff failure causing pain and reduced function.Right shoulder.All components explanted and replaced with reverse shoulder.Doi: (b)(6) 2022; doe: (b)(6) 2024.
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : revision of total shoulder replacement - converted to reverse shoulder due to rotator cuff failure causing pain and reduced function.Right shoulder all components explanted and replaced with reverse shoulder.The product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the crosslink anchor pg glenoid 52 would not contribute to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation was performed for the finished device 113643026/jg3091 and no non-conformances were identified.Device history review : a manufacturing record evaluation was performed for the finished device 113643026/jg3091 and no non-conformances were identified.
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Search Alerts/Recalls
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