BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY FULLFORCE,ACL,STD,CALF,LT,M

    MDR report key: 8734864 · Received June 26, 2019

    Report

    Report Number
    9616086-2019-00034
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    July 6, 2018
    Report Date
    June 25, 2019
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    PMA / PMN Number
    EXERMPT
    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) FACILITY IN (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. ONE FULLFORCE,ACL,STD,CALF,LT,M (PART NUMBER 11-0259-3, LOT NUMBER 011818) WAS RETURNED FOR EVALUATION. THE PRODUCT WAS EVALUATED. ALL THE COMPONENTS ARE IN GOOD CONDITION. FLEXION IS GOOD. NO PROBLEM OR FAULT WAS FOUND. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE REPORTED PRODUCT. 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 WAS WORKING AS A POLICE OFFICER AND WAS ATTEMPTING TO SUBDUE A SUSPECT. PATIENT WAS RUNNING TOWARD THE SUSPECT AND BELIEVED THE POLICE CANINE TO BE ON HIS LEASH. AS THE PATIENT WAS RUNNING TOWARD THE SUSPECT, THE CANINE FOCUSED ON THE PATIENT AND HE WAS NOT ON HIS LEASH. THE CANINE WENT TOWARD THE PATIENT, FORCING THE PATIENT TO ATTEMPT TO STOP QUICKLY. THE PATIENT WAS ON GRASS WHEN ATTEMPTING TO STOP. BOTH OF THE PATIENT'S KNEES BUCKLED AND SLID UNDERNEATH AS THE PATIENT FELL TO THE GROUND. THE CANINE THEN PROCEEDED TO ATTACK THE PATIENT. UPON STANDING UP, THE PATIENT'S KNEE WAS IN EXTREME DISCOMFORT. THE PATIENT WAS WEARING THE BRACE AT THE TIME OF THE INCIDENT. MAGNETIC RESONANCE IMAGING (MRI) CONFIRMED THE ANTERIOR CRUCIATE LIGAMENT (ACL) AND POSTERIOR CRUCIATE LIGAMENT (PCL) WERE TORN. SURGERY WAS CONDUCTED TO REPAIR BOTH LIGAMENTS, FOLLOWED BY AN EVENTUAL SECOND SURGERY TO REMOVE SCAR TISSUE. THE PATIENT REPORTEDLY HAD 114 PHYSICAL THERAPY SESSIONS BEFORE RETURNING TO WORK AND WAS PRESCRIBED PAIN MEDICATION ALONG WITH ANTI-INFLAMMATORY MEDICATION FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530458 DONJOY FULLFORCE,ACL,STD,CALF,LT,M JOINT, KNEE, EXTERNAL BRACE ITQ DJO, LLC 11-0259-3 011818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention