BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANTS

    MDR report key: 9218147 · Received October 22, 2019

    Report

    Report Number
    1221934-2019-59147
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    August 5, 2016
    Report Date
    October 17, 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. 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: XU H., LEEK.,(2016), MODIFIED BROSTROM PROCEDURE FOR CHRONIC LATERAL ANKLE INSTABILITY IN PATIENTS WITH GENERALIZED JOINT LAXITY, THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 44, NO. 12, PAGES 3152-3157 (KOREA, SOUTH) DOI: 10.1177/0363546516657816. THIS STUDY EMPHASIZES TO COMPARE THE CLINICAL RESULTS OF THE MODIFIED BROSTROM PROCEDURE FOR CHRONIC LATERAL ANKLE INSTABILITY IN PATIENTS WITH OR WITHOUT GJL. THE PATIENTS EVALUATED IN THE COURSE OF THIS STUDY: FROM JANUARY 2005 TO DECEMBER 2012, A TOTAL OF 121 PATIENTS AGE AT THE TIME OF SURGERY WAS 18 AND 60 YEARS WHO UNDERWENT THE MODIFIED BROSTROM PROCEDURE WERE RETROSPECTIVELY ANALYZED. THE PATIENTS WERE FURTHER DIVIDED INTO TWO GROUPS: LAXITY AND NONLAXITY GROUP. THE LAXITY GROUP CONSISTED OF 21 MEN AND 23 WOMEN WITH A MEAN AGE OF 34.6 YEARS (RANGE, 18-60 YEARS) AND MEAN FOLLOW-UP DURATION OF 43.3 MONTHS (RANGE, 24-96 MONTHS). THE NONLAXITY GROUP CONSISTED OF 35 MEN AND 21 WOMEN WITH A MEAN AGE OF 35.3 YEARS (RANGE, 18-60 YEARS) AND MEAN FOLLOW-UP DURATION OF 42.9 MONTHS (RANGE, 24-97 MONTHS). BROSTROM PROCEDURE WAS PERFORMED WITH BONE TUNNEL AND SUTURE ANCHOR TECHNIQUES. THE SUTURE TECHNIQUE WAS PERFORMED BY USING A SINGLE SUTURE ANCHOR WITH A NONABSORBABLE 4-STRAND SUTURE (FASTIN RC; DEPUY MITEK), WHICH WAS INSERTED INTO THE CENTER OF THE ANATOMIC FOOTPRINT OF THE ATFL AND CFL. THE CLINICAL AND RADIOGRAPHIC EVALUATIONS WERE PERFORMED PREOPERATIVELY AND POSTOPERATIVELY AT 3 MONTHS, 6 MONTHS, 1 YEAR, AND THEN THEREAFTER ANNUALLY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 5 PATIENTS HAD POOR SCORES ACCORDING TO KARLSSON SCORES OF THE LAXITY GROUP. 3 PATIENTS HAD POOR SCORES ACCORDING TO AOFAS SCORES OF THE LAXITY GROUP. THE RATES OF MAJOR COMPLICATIONS INCLUDING RUPTURES AND RECURRENT LATERAL ANKLE INSTABILITIES WERE 5 PATIENTS AND 1 PATIENT IN THE LAXITY GROUP AND NONLAXITY GROUP. THERE WERE 5 CASES OF FAILURE IN THE LAXITY GROUP, WITH BEIGHTON SCORES OF 7 IN 2 PATIENTS AND 9 IN 3 PATIENTS. TWO PATIENTS WERE MILITARY MEN AND HIGHLY ACTIVE PERSONS. THERE WAS NO DIFFERENCE IN FAILURE RATES BY THE FIXATION TECHNIQUE WITH A BONE TUNNEL OR SUTURE ANCHOR; THERE WERE 3 PATIENTS FOR EACH TECHNIQUE. THE MINOR COMPLICATION RATES WERE 3 PATIENTS AND 5 PATIENTS IN THE LAXITY GROUP AND NONLAXITY GROUP, RESPECTIVELY, INCLUDING LOSS OF ANKLE RANGE OF MOTION, SUPERFICIAL INFECTIONS, AND SURAL NERVE IRRITATION. THREE PATIENTS (1 PATIENT IN THE LAXITY GROUP AND 2 PATIENTS IN THE NONLAXITY GROUP) DEVELOPED SUPERFICIAL WOUND INFECTIONS AND WERE TREATED BY WOUND DRESSINGS TO FIND THE ANTIBIOTIC MEDICATION. ONE FEMALE PATIENT IN THE NONLAXITY GROUP HAD A SURAL NERVE INJURY. THIS REPORT IS FOR AN UNKNOWN MITEK SINGLE SUTURE ANCHOR WITH NONABSORBABLE 4-STRAND SUTURE, FASTIN RC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015298 UNK - IMPLANTS SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention