BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7824821 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75504
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? 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: INTERNATIONAL ORTHOPAEDICS. 2018; 42: 927 938. DOI: HTTPS://DOI.ORG/10.1007/S00264-018-3770-9.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SURVIVAL, COMPLICATIONS AND FUNCTIONAL OUTCOMES OF CEMENTED MEGAPROSTHESES FOR HIGH-GRADE OSTEOSARCOMA AROUND THE KNEE" AUTHORS: CHUNLIN ZHANG, JIANPING HU, KUNPENG ZHU, TAO CAI, XIAOLONG MA CITATION: INTERNATIONAL ORTHOPAEDICS. 2018; 42: 927 938. DOI: HTTPS://DOI.ORG/10.1007/S00264-018-3770-9. THE AUTHORS INITIATED A RETROSPECTIVE STUDY ON THE LONG-TERM SURVIVAL OF CEMENTED ENDOPROSTHESES FOR BONE TUMORS AROUND THE KNEE TO ANSWER THE FOLLOWING QUESTIONS: WHAT WAS THE SURVIVAL OF THESE PATIENTS? WHAT WAS THE OVERALL SURVIVAL OF CEMENTED PROSTHESES AROUND THE KNEE? WHAT TYPES OF FAILURES WERE OBSERVED IN THESE RECONSTRUCTIONS? DID THE SURVIVAL AND COMPLICATIONS VARY ACCORDING TO THE SITE OF THE IMPLANT? WHAT WAS THE FUNCTIONAL RESULT AFTER CEMENTED PROSTHESIS REPLACEMENT AROUND THE KNEE? FROM JANUARY 2006 TO DECEMBER 2013, A TOTAL OF 108 CONSECUTIVE PATIENTS (69 MALE AND 39 FEMALE PATIENTS) WITH AN AVERAGE AGE OF 25 YEARS, WHO HAD MATURE BONE DEVELOPMENT AS EVIDENCED BY IMAGING EXAMINATIONS, UNDERWENT 108 CEMENTED ENDOPROSTHETIC KNEE REPLACEMENTS FOR OSTEOSARCOMA RESECTION. DURING THE SURGICAL PROCEDURE IN CASES IN WHICH AN EXTENSOR MECHANISM RECONSTRUCTION WAS REQUIRED, NON-ABSORBABLE SUTURES WERE RUN THROUGH DESIGNATED HOLES IN THE TIBIAL COMPONENT TO FIX THE DETACHED HAMSTRINGS AND REMAINING LIGAMENTS USING ETHIBOND SUTURES (ETHICON) IN AN IMBRICATED FASHION AND REINFORCE THE RECONSTRUCTION WITH A MEDIAL GASTROCNEMIUS FLAP. REPORTED COMPLICATION INCLUDED WOUND HEALING DISORDER (N-9) WHICH REQUIRED DEBRIDEMENT (N-6) AND FLAP ROTATION (N-3). IN CONCLUSION, LIMB SALVAGE SURGERY USING A CEMENTED PROSTHESIS IS A GOOD OPTION FOR TREATING BONE TUMORS SURROUNDING THE KNEE WITH ACCEPTABLE ONCOLOGICAL RESULTS ENSURED BY STANDARDIZED CHEMOTHERAPY. THIS TECHNIQUE CAN PRESERVE GOOD LIMB FUNCTION WITH A HIGH PROSTHESIS SURVIVAL RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666338 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention