BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GRYPHON

    MDR report key: 9267237 · Received November 1, 2019

    Report

    Report Number
    1221934-2019-59379
    Event Type
    Injury
    Date Received
    November 1, 2019
    Report Date
    October 29, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SANG-JIN SHI ET AL, 2017 ¿CRITICAL VALUE OF ANTERIOR GLENOID BONE LOSS THAT LEADS TO RECURRENT GLENOHUMERAL INSTABILITY AFTER ARTHROSCOPIC BANKART REPAIR¿, THE AMERICAN JOURNAL OF SPORTS MEDICINE VOLUME 45 NUMBER 9 PAGES 1975-1981, (KOREA). THE STUDY EMPHASIZES ON: TO DETERMINE THE CRITICAL VALUE OF ANTERIOR GLENOID BONE LOSS THROUGH THE USE OF PREOPERATIVE, THREE DIMENSIONALLY RECONSTRUCTED COMPUTED TOMOGRAPHY (3D-CT) OF THE GLENOID BASED ON CLINICAL OUTCOMES THAT LED TO RECURRENCES AFTER ARTHROSCOPIC BANKART REPAIR IN PATIENTS VIRITH SYMPTOMATIC ANTERIOR SHOULDER INSTABILITY. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: FROM 2010 TO 2014, 169 PATIENTS MET THE INCLUSION CRITERIA: 158 MEN AND 11 WOMEN, WITH AN AVERAGE AGE OF 23.0 ± 5.1 YEARS (RANGE, 16-32 YEARS) AT THE TIME OF SURGERY. GROUPS A (ANTERIOR GLENOID BONE LOSS <17.3%) AND B (>17.3%) COMPRISED 134 AND 35 PATIENTS, RESPECTIVELY. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC BANKART REPAIR. THE MEAN FOLLOW-UP PERIOD WAS 28.5 ± 9.8 MONTHS (RANGE, 24-72 MONTHS). THE DEVICES INVOLVED WERE ONE DOUBLE-LOADED BIOABSORBABLE SUTURE ANCHOR (GRYPHON; MITEK). COMPLICATIONS MENTIONED IN THE ARTICLE. OF 5 PATIENTS WITH STABILIZATION SURGERY FAILURE IN GROUP A, 4 PATIENTS UNDERWENT REVISION ARTHROSCOPIC BANKART REPAIR. IN GROUP B, 10 PATIENTS HAD REDISLOCATION DUE TO LOW-ENERGY TRAUMATIC EPISODES. FIVE PATIENTS HAD SUBJECTIVE SYMPTOMS OF INSTABILITY WITHOUT TRAUMA. OF 15 PATIENTS WITH FAILURE IN GROUP B, 14 UNDERWENT REVISION SURGERY, INCLUDING 6 WHO UNDERWENT THE LATARJET PROCEDURE AND 8 WHO UNDERWENT REVISION ARTHROSCOPIC BANKART REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059651 UNKNOWN GRYPHON SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention