VICRYL RAPIDE

Description of Event or Problem

Title: Groningen TMJ total joint replacement prosthesis: 3 to 7-year follow-up on surgical and patient reported outcomes. The aim of this prospective study was to assess the 3 to 7-year follow-up outcomes of Fourteen patients (13 female, 1 male) who had received a patient-specific G-TMJ-TJR, with a minimum follow-up period of 24 months, were include, between (b)(6) 2017 and (b)(6) 2022, with a minimum follow-up period of 24 months. Vicryl 4-0 (ETH) was used for wound closure during the TMJ prosthesis implantation procedure. Vicryl Rapide 4-0 (ETH) was specifically used for intracutaneous (subcuticular) skin closure of the surgical incisions during TMJ prosthesis implantation.Reported Complications:Vicryl 4-0 (ETH).Vicryl Rapide 4-0 (ETH).Patients (n=14).Patient #10Persistent chronic pain (n=1).Treatment: not reported.Patient #14Increased pain (n=1).Treatment: not reported.Patient (n=?)Dislocation of the UHMWPE neo-disc was observed (n=1).Treatment: Surgical replacement of the neo-disc with a 1 mm taller version.Temporary weakness (n=3)Treatment: not reported.In conclusion, this study shows considerable functional improvement compared to a prior follow up of a former G-TMJ-TJR study. This indicates that thorough 3D planning, subsequent patient-specific modelling, and accurate guided placement of the G-TMJ-TJR improves clinical outcomes significantly.

Additional Manufacturer Narrative

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 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. Attempts are being 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events.D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.Citation:J Craniomaxillofac Surg. 2025 Dec;53(12):2098-2105. https://doi.org/10.1016/j.jcms.2025.09.008 Epub 2025 Oct 10. PMID: 41076314.