BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 11635318 · Received April 8, 2021

    Report

    Report Number
    2210968-2021-03157
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    December 23, 2020
    Report Date
    March 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 06/07/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WE WISH TO CLARIFY THAT WE DO NOT BELIEVE THAT ETHICON PRODUCTS USED IN THE STUDY (ETHIBOND SUTURE AND PROLENE MESH) CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS (DISCLOCATION OF PROTHESIS, DEEP INFECTION AND WOUND COMPLICATIONS/FAILURE OF COVERAGE) DESCRIBED IN THE ARTICLE. ALSO, WE DO NOT BELIEVE THERE IS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE MESH AND ETHIBOND SUTURE). ON THE CONTRARY, OUR RESULTS SHOW THAT PROLENE MESH CAN BE USED SAFELY AND EFFECTIVELY FOR RECONSTRUCTION OF SOFT TISSUE DEFECTS IN ONCOLOGICAL SURGERIES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO CLARIFY 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 ETHICON PRODUCT (PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS (DISLOCATION OF PROTHESIS, DEEP INFECTION, WOUND COMPLICATIONS/FAILURE OF COVERAGE, EXTENSION LAG, ASEPTIC WOUND NECROSIS AND WOUND DEHISCENCE) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE MESH AND ETHIBOND SUTURE) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (DISLOCATION OF PROTHESIS, DEEP INFECTION, WOUND COMPLICATIONS/FAILURE OF COVERAGE, EXTENSION LAG, ASEPTIC WOUND NECROSIS AND WOUND DEHISCENCE). WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. IF AVAILABLE, PLEASE PROVIDE WHAT PRODUCT CODES/LOT NUMBERS OF PROLENE MESH AND ETHIBOND SUTURE WERE USED IN THESE CASES. CITATION: JOURNAL OF CLINICAL ORTHOPAEDICS AND TRAUMA. 2021; 16: 195-201. DOI: HTTPS://DOI.ORG/10.1016/J.JCOT.2020.12.029. PLEASE SEE ARTICLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED 2210968-2021-03156.

    Description of Event or Problem · 1

    TITLE: OUTCOMES OF MAJOR MUSCULOSKELETAL ONCOLOGICAL RECONSTRUCTIONS USING PROLENE MESH-A RETROSPECTIVE ANALYSIS FROM A TERTIARY REFERRAL CENTRE THE AIM OF THIS RETROSPECTIVE STUDY FROM A PROSPECTIVELY MAINTAINED BONE TUMOR DATABASE IS TO FIND OUT WHETHER USE OF PROLENE MESH FOR SOFT TISSUE RECONSTRUCTION FOLLOWING RESECTION OF BONE TUMORS (1) ENHANCES THE STABILITY OF THE RECONSTRUCT OR (2) INCREASES THE RISK OF DEEP INFECTION. BETWEEN JANUARY 2017 TO JUNE 2019, A TOTAL OF 116 PATIENTS (68 MALES AND 48 FEMALES; MEDIAN AGE = 22.5 YEARS) UNDERWENT SOFT TISSUE RECONSTRUCTION FOLLOWING RESECTION OF BONE TUMORS. 39 PATIENTS HAD TUMORS OF PROXIMAL TIBIA, 23 OF PROXIMAL FEMUR, 25 OF PROXIMAL HUMERUS, 24 OF PELVIS, AND FIVE TUMORS AT OTHER SITES. APPROXIMATELY TWO-THIRDS (62.9%) OF OUR PATIENTS UNDERWENT ENDOPROSTHETIC RECONSTRUCTION WHILE THE REST UNDERWENT EITHER BIOLOGICAL OR CEMENT SPACER RECONSTRUCTIONS. SURGERY WAS PERFORMED USING PROLENE MESH (ETHICON) IN ALL CASES AND INTERRUPTED NONABSORBABLE SUTURES (ETHIBOND NO. 5; ETHICON) IN PROXIMAL FEMUR ENDOPROSTHETIC RECONSTRUCTION. REPORTED COMPLICATIONS INCLUDED IN THE PROXIMAL FEMUR ENDOPROSTHESIS WERE DISLOCATION OF PROSTHESIS (N=2), ONE WAS MANAGED WITH CLOSED REDUCTION UNDER ANAESTHESIA FOLLOWED BY TRACTION FOR 6 WEEKS; THE OTHER ALSO HAD DEEP INFECTION (N=1) WHICH REQUIRED AGGRESSIVE DEBRIDEMENT, PROSTHESIS AND MESH REMOVAL AND CEMENT SPACER; WOUND COMPLICATIONS/FAILURE OF COVERAGE (N=3) WHICH WERE MANAGED CONSERVATIVELY. IN THE PROXIMAL TIBIA ENDOPROSTHESIS, EXTENSION LAG (N=8) WITH A MEAN OF 2.3° WAS REPORTED AND MEAN FLEXION AT THE KNEE WAS 94.1° (RANGE 70-110°); ASEPTIC WOUND NECROSIS (N=8), OF WHICH ONLY ONE REQUIRED DEBRIDEMENT AND SPLIT THICKNESS SKIN GRAFTING (STSG). IN THE PELVIS RECONSTRUCTION, DEEP INFECTION (N=2) WHICH REQUIRED DEBRIDEMENT AND MESH REMOVAL; WOUND DEHISCENCE (N=1) WHICH WAS MANAGED CONSERVATIVELY WITH REGULAR DRESSINGS. IN THE OTHER GROUP, DEEP INFECTION (N=1) WAS OBSERVED. IN CONCLUSION, PROLENE MESH IS A USEFUL TOOL TO RECONSTRUCT THE SOFT TISSUE DEFECTS FOLLOWING BONE TUMOR RESECTIONS. IT IS READILY AVAILABLE, RELIABLE AND PROVIDES REPRODUCIBLE RESULTS, WITH NO ADDED RISK OF WOUND COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535467 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention