BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18705231 · Received February 14, 2024

    Report

    Report Number
    2210968-2024-01372
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    February 28, 2020
    Report Date
    February 14, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITIATION: JOURNAL OF ORTHOPAEDIC SCIENCE 25 (2020) 992-998 HTTPS://DOI.ORG/10.1016/J.JOS.2020.01.014.

    Description of Event or Problem · 0

    TITLE: INSUFFICIENT INTEGRITY OF PARTIAL ARTICULAR SURFACE TENDON AVULSION LESIONS AFTER ARTHROSCOPIC TRANS-TENDON REPAIR: COMPARISON WITH INTEGRITY AFTER ARTHROSCOPIC REPAIR AFTER CONVERSION TO A FULL THICKNESS TEAR THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE INTEGRITY OF THE REPAIRED ROTATOR CUFF BASED ON SECOND-LOOK ARTHROSCOPY AND TO COMPARE THE ABOVE TWO REPAIR TECHNIQUES. BETWEEN (B)(6) 2008 AND (B)(6) 2011, A TOTAL OF 37 SHOULDERS WITH PARTIAL ARTICULAR SURFACE TENDON AVULSION (PASTA) LESIONS WHO WERE REPAIRED ARTHROSCOPICALLY WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS: TRANS TENDON REPAIR (GROUP P) WITH 18 PATIENTS (14 MALE AND 4 FEMALE), A MEAN AGE OF 26.8 YEARS, AND A MEAN FOLLOW-UP OF 29.3 MONTHS. 10 OF THESE PATIENTS FROM GROUP P UNDERWENT SECOND-LOOK ARTHROSCOPY WHILE THE REMAINING 8 DID NOT. REPAIR AFTER CONVERSION TO A FULL THICKNESS TEAR (GROUP C) WITH 19 PATIENTS (10 MALE AND 9 FEMALE), A MEAN AGE OF 48.8 YEARS, AND A MEAN FOLLOW-UP OF 30.1 MONTHS. 10 OF THESE PATIENTS FROM GROUP C ALSO UNDERWENT SECOND-LOOK ARTHROSCOPY WHILE THE REMAINING 9 DID NOT. SECOND-LOOK ARTHROSCOPY WAS DONE AT A MINIMUM OF 3 MONTHS AFTER INITIAL SURGERY, WITH THE MEAN INTERVAL UNTIL SECOND-LOOK ARTHROSCOPY BEING 5.6 MONTHS IN GROUP P AND 5.1 MONTHS IN GROUP C. THE REASONS FOR SECOND-LOOK ARTHROSCOPY WERE PAIN WITH CONTRACTURE IN THE MAJORITY OF THE PATIENTS, AND MUSCLE WEAKNESS AT ABDUCTION IN PATIENT. DURING A TRANS-TENDON REPAIR, THE DEPTH OF THE ROTATOR CUFF TEAR WAS EVALUATED BY USING A 4.5 MM FULL RADIUS SHAVER, THEN A DOUBLE-LOADED METALLIC SUTURE ANCHOR WAS INSERTED THROUGH THE ROTATOR CUFF TENDON. AN 18-GAUGE NEEDLE WAS INSERTED AND A 2-0 PROLENE SUTURE WAS PASSED THROUGH THE SPINAL NEEDLE FOR RETRIEVAL THROUGH THE ANTERIOR PORTAL. ONE END OF THE PROLENE SUTURE WAS TIED TO ONE OF THE SUTURE ANCHOR THREADS OUTSIDE THE ANTERIOR PORTAL AND THE OTHER END OF THE PROLENA SUTURE WAS PULLED OUT. REPORTED COMPLICATIONS INCLUDE 4 PATIENTS WITH PARTIAL CONTINUITY, 3 PATIENTS FAILURE (REPAIRED ROTATOR CUFF WAS COMPLETELY ATTACHED TO THE GREATER TUBEROSITY OR WAS TORN), 8 PATIENTS HAD POSTOPERATIVE CONTRACTURE, CONTRACTURE OF THE ROTATOR INTERVAL WAS IDENTIFIED IN 7 SHOULDERS, SEVERE CONTRACTURE OF THE POSTERIOR CAPSULE WAS RECOGNIZED IN 5 SHOULDERS, WHILE SLIGHT CONTRACTURE WAS FOUND IN 2 SHOULDERS, PAIN STILL OCCURRED IN 6 SHOULDERS, MUSCLE WEAKNESS AT ABDUCTION WAS PROBLEMATIC FOR 1 SHOULDER, ADHESIONS OF THE SUBACROMIAL BURSA WERE SEEN IN ALL SHOULDERS. IN CONCLUSION, SECOND-LOOK ARTHROSCOPY REVEALED THAT THE INTEGRITY OF THE ROTATOR CUFF AFTER TRANS-TENDON REPAIR OF SEVERE PASTA LESIONS WAS OFTEN UNSATISFACTORY IN PATIENTS WITH SYMPTOMATIC SHOULDER. ON THE OTHER HAND, COMPLETE CONTINUITY OF THE ROTATOR CUFF WAS SEEN IN MOST SHOULDERS UNDERWENT ARTHROSCOPIC REPAIR AFTER CONVERSION TO A FULL THICKNESS TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529375 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention