BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY ARMOR FP, ACL,STD,RT,M

    MDR report key: 8734870 · Received June 26, 2019

    Report

    Report Number
    9616086-2019-00028
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    November 30, 2017
    Report Date
    June 25, 2019
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF AN AUDIT OF THE DJ ORTHOPEDICS (B)(4), FDA ISSUED A FINDING ON 13 DECEMBER 2018 THAT "PROCEDURES FOR RECEIVING, REVIEWING, AND EVALUATING COMPLAINTS BY A FORMALLY DESIGNATED UNIT HAVE NOT BEEN ADEQUATELY ESTABLISHED." THIS REPORT IS BEING SUBMITTED AS PART OF DJO'S EFFORTS TO ADDRESS THIS FINDING. DEVICE EVALUATED BY MFR: ONE ARMOR FP, ACL,STD,RT,M (PART NUMBER 11-1442-3, LOT NUMBER 040417) WAS RETURNED FOR EVALUATION. THE PRODUCT WAS VISUALLY EVALUATED. THE BRACE HAS EXCESSIVE USE; THE HINGE HOOK WAS FOUND UNGLUED, BUT IT CANNOT BE DETERMINED IF THIS WAS THE CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER. THE FLEXION IS SUFFICIENT. COMPLAINT DATA FOR SIMILAR PRODUCTS AND ISSUES GOING BACK 9 MONTHS HAS BEEN REVIEWED. THE TREND INDICATES THAT REPORTED CUSTOMER COMPLAINTS ARE WITHIN CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PLAYING BASKETBALL WHILE WEARING HER ARMOR FP BRACE. SHE WAS PLAYING DEFENSE, WENT TO CUT, FELT A "POP", AND FELL TO THE GROUND. SHE RE-TORE HER ANTERIOR CRUCIATE LIGAMENT (ACL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530465 DONJOY ARMOR FP, ACL,STD,RT,M JOINT, KNEE, EXTERNAL BRACE ITQ DJO, LLC 11-1442-3 070417

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention