Catalog Number 545032500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Joint Laxity (4526); Unspecified Tissue Injury (4559)
|
Event Date 10/19/2023 |
Event Type
Injury
|
Event Description
|
Patient complains of painful tka with instability noted on exam.A thicker insert trial was attempted which addressed the instability, however, the patient had significant patella baja rendering the knee to be unacceptable in the surgeons opinion.All components were removed, joint line was shifted distally and revision took place uneventfully.No patient harm occurred.The index procedure was performed with trumatch guides.All components were appropriately sized, aligned and were well fixed.No poly wear was noted.No delay occurred.Doi: (b)(6) 2020.Dor: (b)(6) 2023.Affected side: right knee.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Dmf# - 13704.Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements.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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|
|