BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 24650642 · Received March 20, 2026

    Report

    Report Number
    2210968-2026-02878
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    November 27, 2024
    Report Date
    March 20, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. 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: ARTHROSCOPY. 2025 JUL;41(7):2248-2258. HTTPS://DOI.ORG/10.1016/J.ARTHRO.2024.11.096. EPUB 2024 DEC 11. PMID: 39672244.

    Description of Event or Problem · 0

    TITLE: COMBINED SUPERIOR CAPSULAR RECONSTRUCTION USING FASCIA LATA AUTOGRAFT AND LOWER TRAPEZIUS TRANSFER USING ACHILLES TENDON ALLOGRAFT ARE ASSOCIATED WITH IMPROVED SURGICAL OUTCOMES IN PATIENTS WITH CHRONIC POSTEROSUPERIOR IRREPARABLE MASSIVE ROTATOR CUFF TEARS. THE AIM OF THIS STUDY IS TO EVALUATE THE MINIMUM 12-MONTH CLINICAL AND RADIOLOGIC OUTCOMES OF COMBINED SUPERIOR CAPSULAR RECONSTRUCTION (SCR) AND LOWER TRAPEZIUS TRANSFER (LTT) FOR POSTEROSUPERIOR IRREPARABLE MASSIVE ROTATOR CUFF TEARS (IMRCTS). BETWEEN JUNE 2021 AND APRIL 2023, A TOTAL OF 15 PATIENTS WHO UNDERWENT COMBINED SCR AND LTT USING NO. 2 POLYESTER SUTURE (ETHIBOND; ETHICON [JOHNSON & JOHNSON]) AND POLYPROPYLENE MESH (PROLENE MESH; ETHICON [JOHNSON & JOHNSON]). REPORTED COMPLICATIONS ARE N=2; FASCIA LATA AUTOGRAFT FAILURE TREATMENT: NOT MENTIONED N=2; ACHILLES TENDON ALLOGRAFT TEARS FAILURE TREATMENT: NOT MENTIONED N=?; POST-OPERATIVE VAS SCORE TREATMENT: NOT MENTIONED IN CONCLUSION, SCR-LTT CONTRIBUTES TO SIGNIFICANT PAIN RELIEF AND FUNCTIONAL IMPROVEMENTS WITH A GRAFT HEALING RATE OF 86.7% AT A MINIMUM 12-MONTH FOLLOW-UP IN PATIENTS WITH POST EROSUPERIOR IMRCTS AND HIGH-GRADE FATTY INFILTRATION OF THE INFRASPINATUS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715268 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other