BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9503288 · Received December 20, 2019

    Report

    Report Number
    2210968-2019-91155
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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: KNEE SURG SPORTS TRAUMATOL ARTHROSC (2010) 18:1752-1758 DOI 10.I007/S00167-010-1105-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: ARTHROSCOPIC BANKART REPAIR: RESULTS AND RISK FACTORS OF RECURRENCE OF INSTABILITY." AUTHORS: TAPIO FLINKKILA, PEKKA HYVONEN, PASI OHTONEN, AND JUHANA LEPPILAHTI. CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC (2010) 18:1752-1758 DOI 10.I007/S00167-010-1105-5. THE OBJECTIVE OF THIS STUDY WAS TO DISCOVER THE RECURRENCE RATE OF INSTABILITY AFTER ARTHROSCOPIC BANKART REPAIR AND TO ASSESS RISK FACTORS FOR RECURRENCE, WITH SPECIAL INTEREST IN BONE DEFECTS SEEN ON PREOPERATIVE PLAIN RADIOGRAPHS. A TOTAL OF 182 PATIENTS (132 MALES, 50 FEMALES) UNDERWENT ARTHROSCOPIC BANKART REPAIR (186 SHOULDERS) BETWEEN 2000 2005 FOR INSTABILITY (RECURRENT DISLOCATION OR SUBLUXATION) AFTER INITIAL TRAUMATIC ANTEROINFERIOR SHOULDER DISLOCATION. MEAN AND MEDIAN AGE OF THE PATIENTS AT THE TIME OF SURGERY WAS 28 (SD 9, RANGE 15 58) AND 26, RESPECTIVELY. STANDARD ARTHROSCOPIC TECHNIQUES WERE PERFORMED USING 5 DIFFERENT ANCHORS AND FOUR DIFFERENT SUTURES. ETHIBOND¿ (ETHICON, (B)(4), USA) SUTURES WERE USED IN 123 CASES. THERE WERE 11 PATIENTS WHO EXPERIENCED RECURRENCE WITHOUT A NEW INJURY. THERE WERE 18 PATIENTS WHO REQUIRED FURTHER SURGERY BECAUSE OF RECURRENT INSTABILITY. IN CONCLUSION, THE AUTHORS WERE ABLE TO SHOW THAT IF UNSELECTED PATIENTS WITH INSTABILITY AFTER INITIAL ANTEROINFERIOR SHOULDER DISLOCATION ARE OPERATED ON USING ARTHROSCOPIC BANKART REPAIR WITH SUTURE ANCHORS, THE RATE OF RECURRENCE OF INSTABILITY IS HIGHER THAN PREVIOUSLY REPORTED. AGE <20 IS THE MOST IMPORTANT RISK FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296278 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention