BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7918899 · Received September 28, 2018

    Report

    Report Number
    2210968-2018-76150
    Event Type
    Injury
    Date Received
    September 28, 2018
    Report Date
    September 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT 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 THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: BLASCO A, BAIXAULI E. BMJ CASE REP 2018; DOI: 10.1136/BCR-2017-222854. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : GRANULOMA FORMATION ASSOCIATED WITH PATELLAR TENDON NECROSIS IN RESPONSE TO ETHIBOND CONFIRMED BY HISTOPATHOLOGICAL EXAMINATION" AUTHOR: ALEJANDRO BLASCO, EMILIO BAIXAULI, CITATION: BLASCO A, BAIXAULI E. BMJ CASE REP 2018; DOI: 10.1136/BCR-2017-222854. THE AIM OF THIS STUDY IS TO DESCRIBE A CASE OF DELAYED GRANULOMA FORMATION ASSOCIATED WITH TENDON NECROSIS IN RESPONSE TO ETHIBOND CONFIRMED BY HISTOPATHOLOGICAL EXAMINATION AND TO REVIEW AND DISCUSS THE RELATED LITERATURE. A (B)(6) WOMAN WAS ADMITTED TO THE EMERGENCY ROOM AFTER FALLING DOWN A SET OF STAIRS. SHE COMPLAINED OF KNEE SORENESS, SWELLING, LOSS OF KNEE EXTENSION AND AN ALTERED GAIT PATTERN. A PHYSICAL EXAMINATION REVEALED A PATELLAR TENDON GAP, AND X-RAYS INDICATED PATELLA ALTA WITH NO OTHER REMARKABLE FINDINGS. AN ULTRASOUND EXAMINATION CONFIRMED PATELLAR TENDON RUPTURE AND THE PATIENT AGREED TO OPEN REPAIR. KRAKOW-LIKE REPAIR WITH DOUBLE PATELLAR TUNNEL-LOOP ATTACHMENT WAS PERFORMED WITH #5 ETHIBOND (ETHICON, (B)(4)) SUTURES. THE PATIENT WAS ADVISED NOT TO BEAR WEIGHT, AND A FULL-TIME KNEE EXTENSION ORTHOTIC DEVICE WAS PRESCRIBED. FOUR YEARS AFTER THE REPAIR, THE PATIENT NOTICED PROGRESSIVE KNEE EXTENSION SORENESS AND DISCOMFORT AFTER PARTICIPATING IN SPORTS, DESPITE NOT HAVING SUFFERED ANY TRAUMA. A PHYSICAL EXAMINATION SHOWED KNEE SWELLING AND KNEE EXTENSION IMPAIRMENT. THE PATIENT SHOWED NO SIGN OF INFECTION, AND HER SKIN WAS INTACT. AN X-RAY EXAMINATION SHOWED NO PATELLA ALTA OR OTHER PATHOLOGICAL FEATURES. AN ULTRASOUND EXAMINATION REVEALED PROXIMAL PARTIAL PATELLAR TENDON RUPTURE WITH A SMALL FLUID COLLECTION SURROUNDING THE PARTIAL RUPTURE. BASED ON THESE FINDINGS, THE PATIENT WAS ADVISED TO UNDERGO SURGICAL INTERVENTION DUE TO A SUSPECTED DIAGNOSIS OF RE-RUPTURE. DOUBLE PATELLAR AND QUADRICIPITAL LONGITUDINAL INCISION FOLLOWING PREVIOUS SURGICAL WOUNDS WAS PERFORMED, AND TENDINOSIS, FIBROSIS AND NECROSIS SCAR TISSUE SURROUNDING THE PREVIOUS SUTURE WERE OBSERVED AND EXCISED; SAMPLES WERE SENT FOR HISTOPATHOLOGICAL AND MICROBIOLOGICAL EXAMINATION. STRIPPING OF THE PATELLAR PARATENON WAS PERFORMED. HOWEVER, THE AUTHORS COULD NOT FIND ANY PATELLAR OR QUADRICIPITAL RUPTURE. THE SKIN WAS CLOSED IN A REGULAR MANNER. A MICROBIOLOGICAL EXAMINATION (QUADRICIPITAL AND PATELLAR) INDICATED NO SIGN OF INFECTION. ADDITIONALLY, A HISTOPATHOLOGICAL EXAMINATION OF THE PATELLAR TENDON SHOWED A MACROSCOPIC YELLOWNESS IN THE CENTRAL AREA AND PERIPHERAL WHITENESS THAT MICROSCOPICALLY CORRESPONDED TO VASCULARISED TISSUE, PERIVASCULAR MONONUCLEAR LYMPHOCYTES AND A GIANT CELL FOREIGN BODY REACTION SURROUNDING SYNTHETIC REFRINGENT MATERIAL, TOGETHER WITH NUMEROUS OF POLYMORPHONUCLEAR CELLS SURROUNDING THE NECROTIC TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759661 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention