BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GII ANCHOR

    MDR report key: 9220068 · Received October 22, 2019

    Report

    Report Number
    1221934-2019-59156
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    October 18, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. 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: VALIS, P., ET AL (2003), AN ARTHROSCOPIC SHOULDER STABILIZATION USING ANCHORS, ACTA CHIRURGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CZECHOSL, VOL. 70, PAGES 233-236 (CZECH REPUBLIC). THE STUDY EMPHASIZES ON PRESENTING A CLINICAL EXPERIENCE WITH AN ARTHROSCOPIC TECHNIQUE FOR ANTERIOR STABILIZATION OF THE SHOULDER WITH AN ANCHOR IN 64 PATIENTS WHO HAD RECURRENT ANTERIOR GLENOHUMERAL INSTABILITY. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: FROM APRIL 1999 TO JANUARY 2002, 64 PATIENTS WITH UNSTABLE SHOULDER JOINT WERE TREATED USING ARTHROSCOPIC SURGERY, INCLUDING 44 MEN. THE AVERAGE AGE OF THE PATIENTS WAS 27 YEARS (RANGE, 16 TO 52 YEARS). THE POST-SURGICAL FOLLOW-UP PERIOD WAS FROM 3 TO 36 MONTHS, WITH AN AVERAGE OF 18 MONTHS. AFTER THE SURGERY, A BRACE WAS APPLIED AND LEFT FOR 5 WEEKS. DURING THIS TIME, ONLY THE ISOMETRIC MUSCLES ON THE FIXED UPPER EXTREMITY WERE EXERCISED. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC SHOULDER JOINT STABILIZATION FOR ANTERIOR STABILIZATION OF THE SHOULDER. THE DEVICES INVOLVED WERE: MITEK ANCHOR, AND ANOTHER ANCHOR DEVICE. COMPLICATION MENTIONED IN THE ARTICLE: 3 PATIENTS HAD POOR RESULTS DUE TO RE-LUXATION; IN 1 CASE, THE RECURRENT LUXATION HAPPENED DUE TO CONTACT SPORT; AND IN THE REMAINING 2, IT OCCURRED ATRAUMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014707 UNKNOWN GII ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention