MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Failure of Implant (1924); Sepsis (2067)

Event Date 09/02/2023

Event Type  Injury  

Manufacturer Narrative

(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 ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.An attempt has been made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-02647 and 2210968-2024-02648.Citation: knee surgery, sports traumatology, arthroscopy (2023) 31:4816¿4823.Https://doi.Org/10.1007/s00167-023-07538-1.

Event Description

Title: discoid lateral meniscus instability in children: part ii.: repair first to minimise the saucerisation.The aim of this retrospective, single-centred, consecutive-case study was to evaluate mid-term clinical results in discoid lateral meniscus (dlm) paediatric patients treated arthroscopically with the ¿meniscoplasty¿suture¿ technique, and to investigate the factors related to surgical failures.Between january 2007 and december 2015, a total of 60 knees from 51 patients (22 males and 29 females) with dlm treated arthroscopically by the ¿meniscoplasty or saucerisation¿suture¿technique were included in the study.The median (range) age of the whole group of 51 patients at surgery was 11 (4¿17) years.The partial meniscectomy (¿meniscoplasty-saucerization¿) only involved the excessive central discoid portion.A minimum of 3 inside-out sutures were performed per knee.Sutures were placed every 4 mm.A non-absorbable monofilament was used (ethylon #0) for the first patients of the series.This monofilament was progressively replaced by a stronger non-absorbable braided suture (mersilene #1¿ ethicon®).Reported complications septic arthritis (n=1) and failure with a new meniscal tear (n=11).In conclusion, in contrast to adult knees, symptomatic discoid lateral meniscus is rarely stable in children (5%).Meniscal repair is effective to preserve the meniscus tissue, but revision repair became necessary in 18% of the cases and was initially successful.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18858503
• MDR Text Key: 337184500
• Report Number: 2210968-2024-02647
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention