BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7806396 · Received August 22, 2018

    Report

    Report Number
    2210968-2018-75333
    Event Type
    Injury
    Date Received
    August 22, 2018
    Report Date
    August 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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 PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: J SHOULDER ELBOW SURG (2013) 22, 1495-1506, HTTP://DX.DOI.ORG/10.1016/J.JSE.2013.04.018. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : CAN SURGEONS PREDICT WHAT MAKES A GOOD HEMIARTHROPLASTY FOR FRACTURE?" AUTHOR: PASCAL BOILEAU, MDA,*, MATTHIAS WINTER, MDB, ALEC CIKES, MDC, YUNG HAN, MDA, MICHEL CARLES, MD, PHDD, GILLES WALCH, MDE, DANIEL G. SCHWARTZ, MD CITATION: J SHOULDER ELBOW SURG (2013) 22, 1495-1506, HTTP://DX.DOI.ORG/10.1016/J.JSE.2013.04.018. THE AIMS OF THIS RETROSPECTIVE STUDY WERE (1) TO IDENTIFY THE RISK FACTORS FOR TUBEROSITY COMPLICATIONS AND POOR FUNCTIONAL OUTCOMES AND (2) TO COMPARE A STANDARD HUMERAL STEM WITH A FRACTURE-SPECIFIC HUMERAL STEM IN HEMIARTHROPLASTY FOR THE TREATMENT OF 3- AND 4-PART PROXIMAL HUMERAL FRACTURES. FROM 1991 TO 2005, 60 PATIENTS (61 SHOULDERS) LEFT AVAILABLE FOR A FOLLOW-UP AND INCLUDED IN THE RETROSPECTIVE STUDY. THERE WERE 38 WOMEN AND 22 MEN WITH A MEAN AGE OF 67 YEARS (RANGE, 39 TO 86 YEARS). A CONVENTIONAL STANDARD STEM WAS IMPLANTED IN THE FIRST 31 SHOULDERS (GROUP A), AND A SPECIFIC FRACTURE STEM WAS IMPLANTED IN THE NEXT 30 SHOULDERS (GROUP B). DURING THE PROCEDURE, 6 HEAVY, NON-ABSORBABLE SUTURES (NO. 5 ETHIBOND; ETHICON, (B)(4)) WERE USED FOR TUBEROSITY FIXATION: TWO WERE PLACED IN THE INFRASPINATUS, TWO IN THE TERES MINOR, AND TWO IN THE DIAPHYSIS AFTER TWO DRILL HOLES HAD BEEN MADE ON THE LATERAL ASPECT OF THE HUMERUS. INFECTION DEVELOPED IN 1 PATIENT WHICH REQUIRED LAVAGE AND DEBRIDEMENT. IN CONCLUSION, GOOD FUNCTIONAL OUTCOMES CAN BE ANTICIPATED AFTER HEMIARTHROPLASTY FOR PROXIMAL HUMERAL FRACTURES IF THE GREATER TUBEROSITY IS ANATOMICALLY POSITIONED (IE, LATERAL TO THE STEM) AND HEALED AROUND THE PROSTHESIS. THE USE OF A SPECIFIC FRACTURE STEM ALLOWS TO DOUBLE THE RATE OF TUBEROSITY HEALING COMPARED TO A CONVENTIONAL STEM (87% VS. 45%), DECREASES COMPLICATIONS AND IMPROVES SHOULDER FUNCTION. RISK FACTORS ASSOCIATED WITH POOR FUNCTIONAL RESULTS AND ANATOMIC FAILURES ARE (1) PATIENT AGE (MORE THAN OR EQUAL TO 75 YEARS), (2) PATIENT GENDER (WOMEN), AND (3) USE OF A CONVENTIONAL (BULKY) STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648915 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention