BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AAP LOQTEQ® DISTAL LATERAL FEMUR PLATE 4.5 SYSTEM

    MDR report key: 15971395 · Received December 13, 2022

    Report

    Report Number
    3001406084-2020-00019
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    September 24, 2017
    Report Date
    September 28, 2020
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE COULD NOT BE INVESTIGATED DUE TO INSUFFICIENT INFORMATION. NEITHER THE LOT NUMBER OF THE DEVICE, THE SURGICAL REPORT, IMAGES NOR THE EXPLANT WAS PROVIDED, THOUGH THE INFORMATION WERE REQUESTED SEVERAL TIMES. THIS IS A LATE REPORT DUE TO A CORRECTIVE ACTION.

    Description of Event or Problem · 0

    THE PATIENT HAD A PERI PROSTHETIC FRACTURE (TKR) AND A DIST. LATERAL FEMUR PLATE WAS IMPLANTED. AT THE REVISION, 6 WEEKS LATER, THE PLATE WAS FOUND BROKEN MEDIAL. THE PATIENT STARTED FULL WEIGHT BEARING 3 WEEKS POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145964 AAP LOQTEQ® DISTAL LATERAL FEMUR PLATE 4.5 SYSTEM DISTAL LATERAL FEMUR PLATE SYSTEM HRS AAP IMPLANTATE AG PF 4510-11-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention