BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® DIST. LATERAL FEMUR PLATE 4.5, 7/9 HOLES, L 243, R

    MDR report key: 15670537 · Received October 25, 2022

    Report

    Report Number
    3001406084-2020-00030
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    May 28, 2019
    Report Date
    September 28, 2020
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K121494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE PRESENT CASE, A COMPLEX, MORE FRAGMENTARY FEMUR FRACTURE WAS TREATED VERY RIGIDLY. THE 85-YEAR-OLD PATIENT ALSO HAS INFLUENCING COMORBITIES (HTA, PARKINSON). IN ADDITION, DUE TO AGE, IT MUST BE ASSUMED THAT IT WAS NO LONGER POSSIBLE TO CONTROL THE PARTIAL STRESS OF THE AFFECTED EXTREMITY. CLINICAL EXPERT OPINION (UNIVERSITY CLINIC GIESSEN). THE SUPPLY HAS ALWAYS BEEN CARRIED OUT CORRECTLY. FROM THE EXPERT'S POINT OF VIEW, TOO STIFF (BRIDGING TOO SHORT IN THE AREA OF THE FRACTURE ZONE). THE CAUSE OF THE FAILURE, HOWEVER, IS THE LACK OF HEALING, WHICH CAN BE CLEARLY SEEN ON THE AVAILABLE X-RAY IMAGES. FOR EXAMPLE, 6 MONTHS AFTER THE PLATE WAS INSERTED (POST-OP), NO MEDIAL CALLUS FORMATION CAN BE SEEN ON THE LARGE SPIRAL FRAGMENT. FAILURE TO HEAL THE FRACTURE IN COMBINATION WITH A VERY RIGID OSTEOSYNTHESIS MAY HAVE BEEN THE CAUSE OF THE FRACTURE EVENT. IN CONTRAST TO JOINT IMPLANTS, OSTEOSYNTHESIS PLATES ARE ONLY DESIGNED FOR A LIMITED LIFE UNDER LOAD. THE LACK OF BONY CONSOLIDATION THUS EXTENDED THE PERIOD OF IMPLANT LOADING. THIS IS A LATE REPORT DUE TO A CORRECTIVE ACTION.

    Description of Event or Problem · 0

    FRACTURE LOQTEQ® DISTAL. LATERAL FEMUR PLATE AFTER 6 MONTHS POSTOPERATIVELY AFTER MISSING BONE CONSOLIDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774952 LOQTEQ® DIST. LATERAL FEMUR PLATE 4.5, 7/9 HOLES, L 243, R BONE PLATE HRS AAP IMPLANTATE AG PF 4510-09-2 L012

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention