BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22507623 · Received July 15, 2025

    Report

    Report Number
    2210968-2025-08111
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: NOT PROVIDED DOI: NOT PROVIDED.

    Description of Event or Problem · 0

    TITLE: BONY RECONSTRUCTION AFTER INTERNAL HEMIPELVECTOMY: A RETROSPECTIVE ANALYSIS OF 44 PATIENTS UNDERGOING FEMORO-PELVIC PSEUDOARTHROSIS. THE AIM OF THIS STUDY IS TO EVALUATE THE FUNCTIONAL OUTCOMES OF USING POLYPROPYLENE MESH FOR RECONSTRUCTING ACETABULAR DEFECTS FOLLOWING RESECTION OF SARCOMAS, WITH THE GOAL OF ACHIEVING PSEUDO-ARTHROSIS AND ADDRESSING THE CHALLENGES OF BONY FEMORO-PELVIC FUSION AND THE HIGH COMPLICATION RATES ASSOCIATED WITH PROSTHETIC RECONSTRUCTIONS. BETWEEN 2013 AND 2022, 44 PATIENTS HAVING BONE TUMORS OF THE PELVIS UNDERWENT ACETABULAR RESECTIONS AND FEMORO-PELVIC PSEUDOARTHROSIS. COMMONEST HISTOLOGY WAS CHONDROSARCOMA (23). IT WAS PASSED THROUGH THE REMAINING ILIUM/ ISCHIUM/ SACRUM AND WAS TIED TO ITSELF IN PROPER ROTATION WITH HEAVY ETHIBOND SUTURE (ETHICON). REPORTED COMPLICATIONS ARE FLAP NECROSIS (N=6) . TREATMENT: NO T PROVIDED INFECTIONS (N=3) . TREATMENT : NO T PROVIDED NERVE INJURY (N=1) . TREATMENT : NO T PROVIDED VASCULAR INJURY (N=1) . TREATMENT : NO T PROVIDED. IN CONCLUSION, MESH-PSEUDOARTHROSIS IS A VERY SIMPLE RECONSTRUCTION OPTION THAT HAS AN EXCELLENT FUNCTIONAL OUTCOME. IT REDUCES SURGICAL TIME AND ELIMINATES UNCERTAINTIES ABOUT FUSION/JOINT REPLACEMENT. THIS SHOULD BE STRONGLY RECOMMENDED AS A METHOD OF RECONSTRUCTION FOR PATIENTS UNDERGOING ACETABULAR RESECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740536 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other