BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY FULLFORCE,ACL,SHRT CF,RT,M

    MDR report key: 8734869 · Received June 26, 2019

    Report

    Report Number
    9616086-2019-00029
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    November 29, 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 FULLFORCE,ACL,SHRT CF,RT,M (PART NUMBER 11-3220-3, LOT NUMBER 053117) WAS RETURNED FOR EVALUATION. PRODUCT WAS VISUALLY EVALUATED. ITEM WAS USED. THE FLEXION OF THE PRODUCT WAS WORKING WELL. THE LEFT HINGE HOOK WAS UNGLUED AND WAS NOT HOLDING THE PAD BUT THIS WOULD NOT HAVE CONTRIBUTED TO ANY INJURY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE REPORTED PRODUCT WITH LOT NUMBER 053117. THERE WAS NO INFORMATION IN THE DHR THAT WOULD INDICATE A PROBLEM THAT CONTRIBUTED TO THE REPORTED COMPLAINT. 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 RE-TORE HER ANTERIOR CRUCIATE LIGAMENT (ACL) WHILE WEARING THE BRACE AND PARTICIPATING IN AN UNSPECIFIED SPORT. SHE WAS IN A PRACTICE SITUATION AND WAS SHIELDING A PLAYER AS SHE WAS RECEIVING A PASS. SHE WENT TO TURN AND AS THE DEFENDER PUT PRESSURE ON HER, HER LEG SHIFTED INWARDS AND SHE HEARD A POP. A TRAINER WAS ON THE PRACTICE FIELD AND IMMEDIATELY ASSESSED HER INJURY. A SURGERY WAS PERFORMED TO REPAIR THE LIGAMENT ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530464 DONJOY FULLFORCE,ACL,SHRT CF,RT,M JOINT, KNEE, EXTERNAL BRACE ITQ DJO, LLC 11-3220-3 053117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention