BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 13712682 · Received March 9, 2022

    Report

    Report Number
    2210968-2022-01597
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    March 3, 2018
    Report Date
    March 9, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1155/2018/9315815.

    Description of Event or Problem · 0

    TITLE: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY EVALUATING MENISCAL HEALING, CLINICAL OUTCOMES, AND SAFETY IN PATIENTS UNDERGOING MENISCAL REPAIR OF UNSTABLE, COMPLETE VERTICAL MENISCAL TEARS (BUCKET HANDLE) AUGMENTED WITH PLATELET-RICH PLASMA THE PRESENT STUDY AIMED TO INVESTIGATE THE EFFECTIVENESS AND SAFETY OF PLATELET-RICH PLASMA (PRP) APPLICATION IN ARTHROSCOPIC REPAIR OF COMPLETE VERTICAL TEAR OF MENISCUS LOCATED IN THE RED-WHITE ZONE. THIS SINGLE CENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-ARM STUDY INCLUDED 37 PATIENTS WITH COMPLETE VERTICAL MENISCUS TEARS. PATIENTS RECEIVED AN INTRAREPAIR SITE INJECTION OF EITHER PRP OR STERILE 0.9% SALINE DURING AN INDEX ARTHROSCOPY. THE PRIMARY ENDPOINT WAS THE RATE OF MENISCUS HEALING IN THE TWO GROUPS. THE SECONDARY ENDPOINTS WERE CHANGES IN THE INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SCORE, KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS), WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC), AND ANALOG SCALE (VAS) IN THE TWO GROUPS AT 42 MONTHS. SUTURES WERE PLACED VIA THE OUTSIDE-IN TECHNIQUE USING PROLENE SUTURE MATERIAL (ETHICON, SOMERVILLE, NJ, USA). REPORTED COMPLICATION INCLUDED UNHEALED MENISCI(N=9), PARTIALLY HEALED MENISCI (N=1) IN CONCLUSION THE FIRST BLINDED, PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL ON THE ROLE OF PRP AUGMENTATION IN MENISCUS REPAIR. THE FINDINGS OF THIS STUDY INDICATE THAT PRP AUGMENTATION IN MENISCUS REPAIR RESULTS IN A SIGNIFICANT IMPROVEMENT IN THE RATE OF MENISCUS HEALING. PRP WAS FOUND TO IMPROVE THE CHANCES OF MENISCUS HEALING BY OVER SIX TIMES (ODDS RATIO 6.375 - 95% CI 1.35¿30.14). ADDITIONALLY, THE POSSIBILITY OF ADVERSE EVENTS RELATED TO THE USE OF PRP IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759705 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention