BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® DISTAL FEMUR PLATE

    MDR report key: 19486641 · Received June 7, 2024

    Report

    Report Number
    3001406084-2024-00003
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 6, 2024
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K121494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOCKING SCREWS SHOW MARKS ON THE HEAD THREAD WHICH SUGGEST THAT THEY WERE NOT LOCKED INTO THE BONE PLATE AT THE CORRECT ANGLE (LACK OF POSITIVE LOCKING). IT CAN BE ASSUMED THAT THE SCREWS WERE NOT INSERTED ON THE CORRECT AXIS AND THAT THE HEAD THREAD OF THE LOCKING SCREWS WAS INSUFFICIENTLY LOCKED IN THE PLATE THREAD (ONLY FORCE-FIT). A SUFFICIENTLY LARGE FORCE (FACILITATED BY THE HIGH PATIENT WEIGHT) WAS ABLE TO RELEASE THE SCREW HEADS FROM THIS CLAMPING. AS THE SCREWS IN THIS AREA ARE ONLY SCREWED INTO THE CANCELLOUS BONE, THE BONE DID NOT PROVIDE SUFFICIENT COUNTER-LOCKING AND THE SCREWS WERE PULLED LATERALLY OUT OF THE AREA OF THE KNEE CONDYLES BY THE PLATE. DEPENDING ON THE WEAR ON THE SCREW SHAFTS, THIS HAPPENED OVER SEVERAL LOAD CYCLES. THE SUBSEQUENT DISLOCATION OF THE BONE PLATE THEN PROBABLY OCCURRED VERY QUICKLY. THE DESCRIBED FAILURE WAS FURTHER FACILITATED BY: -OVERWEIGHT -PROBABLY MISSING OR EXCESSIVE PARTIAL WEIGHT BEARING DUE TO THE HIGH PATIENT WEIGHT (OBESITY I) -INAPPROPRIATE OSTEOSYNTHESIS (EXPECTED LOAD WAS INSUFFICIENTLY ADDRESSED) -DEVIATION FROM THE SURGICAL TECHNIQUE (DRILLING OF SCREW HOLES WITHOUT DRILL GUIDE).

    Description of Event or Problem · 0

    DISTAL FEMUR OSTEOSYNTHESIS FAILED. FAILURE WAS NOTED INTO TREATMENT/POST-OPERATIVE. THERE WAS NON-UNION AND REFRACTURE OF THE BONE WHICH RESULTED IN LOSS OF ACHIEVED CORRECTION, LOSS OF FRACTURE REDUCTION AND PATIENT NEEDS CORRECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286119 LOQTEQ® DISTAL FEMUR PLATE BONE PLATES HRS AAP IMPLANTATE AG PF 4511-07-2 R048

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention