Catalog Number 198708055 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 04/15/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that the patient dislocated again from a competitive constrained liner.Surgeon choose to remove the competitive cup and place a depuy cup and constrained liner.Unfortunately, after being repeated failures with the competitive liner the surgeon had strong suspicion of infection due to elevated labs and chose to change all modular components and place resorbable antibiotic beads.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: left hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Product code: 198708055 lot number: m3078g manufacturing date: 17-mar-2023 expiration date: 28-feb-2033 quantity manufactured: (b)(6).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 = > product code: 198708055 lot number: m3078g manufacturing date: 17-mar-2023 expiration date: 28-feb-2033 quantity manufactured: (b)(6).Device history review: a manufacturing record evaluation was performed for the finished device , and no non-conformances /manufacturing irregularities were identified.
|
|
Search Alerts/Recalls
|
|