BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PANACRYL

    MDR report key: 9377752 · Received November 26, 2019

    Report

    Report Number
    2210968-2019-90334
    Event Type
    Injury
    Date Received
    November 26, 2019
    Report Date
    November 11, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. CITATION: ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL 22, NO 9 (SEPTEMBER), 2006: PP 962-966; DOI:IO.IOI6/J.ARTHRO.2006.04.109.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : MENISCAL REPAIR WITH THE RAPIDLOC MENISCAL REPAIR DEVICE" AUTHOR : F. ALAN BARBER, M.D., DAVID A. COONS, D.O., AND MICHELI RUIZ-SUAREZ, M.D., CITATION: ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL 22, NO 9 (SEPTEMBER), 2006: PP 962-966; DOI:IO.IOI6/J.ARTHRO.2006.04.109. THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE CLINICAL SUCCESS OF THE RAPIDLOC DEVICE. BETWEEN JULY 2001 AND JANUARY 2004, A TOTAL OF 35 PATIENTS UNDERGOING ARTHROSCOPIC MENISCAL REPAIR WITH THE RAPIDLOC DEVICE WERE INCLUDED IN THE STUDY BUT ONLY 32 OF 35 PATIENTS (MEAN AGE: 30 YEARS, RANGE: 14-53 YEARS) WERE AVAILABLE AT AVERAGE FOLLOW-UP OF 31 MONTHS. THE RAPIDLOC MENISCAL REPAIR DEVICE USED IN THE PROCEDURE CONSISTS OF A SUTURE MADE OF NO. 2 ETHIBOND (ETHICON) OR NO. 2 PANACRYL. COMPLAINTS INCLUDED FAILURE (N=?), THE PATIENTS WITH SIGNIFICANT PAIN, SWELLING, AND LOCKING AFTER MENISCAL REPAIR WERE ARTHROSCOPICALLY EVALUATED AND, AT THE TIME OF THIS REPEAT ARTHROSCOPIC SURGERY, TEARS WERE FOUND AT THE SITE OF PREVIOUS MENISCAL REPAIR. THE MEDIAL MENISCUS REPAIR FAILED 8 MONTHS AFTER THE INDEX PROCEDURE WAS PERFORMED AND DURING THE SECOND ARTHROSCOPIC PROCEDURE UNDERTAKEN TO PERFORM A MEDIAL MENISCECTOMY; EXCORIATION AND GROOVING OF THE MEDIAL FEMORAL CONDYLE (ARTICULAR CARTILAGE) WERE OBSERVED (N=?). THE PATIENT WHO UNDERWENT AN ISOLATED MENISCAL REPAIR DEVELOPED A POSTOPERATIVE INFECTION (N=?) THAT CLEARED WITH ARTHROSCOPIC DEBRIDEMENT AND ANTIBIOTICS. IN CONCLUSION, THE RAPIDLOC MENISCAL REPAIR DEVICE WAS FOUND TO HAVE A CLINICAL SUCCESS RATE OF 87.5%. CLINICAL MEASURES, INCLUDING TEGNER, LYSHOLM, CINCINNATI, AND EKDC, WERE ALL NOTED TO IMPROVE. EARLY DATA SUGGEST THAT THE RAPIDLOC IS AN EFFECTIVE ALL-INSIDE REPAIR DEVICE, BUT LONGER-TERM FOLLOW-UP IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170761 UNK_PANACRYL SUTURE, SURGICAL, ABSORBABLE GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention