BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® DISTAL FEMURPLATE 4.5

    MDR report key: 20993654 · Received December 20, 2024

    Report

    Report Number
    3001406084-2024-00006
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    August 14, 2024
    Report Date
    December 18, 2024
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K210043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE REPEATED REQUESTS, NO FURTHER INFORMATION ON THE CASE WAS PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE, IT WAS NOT POSSIBLE TO ADEQUATELY ANALYZE THE CAUSES. THE INSPECTION OF THE DHR DID NOT REVEAL ANY DEVIATIONS FROM THE SPECIFICATION. THE SCREWS MAY NOT HAVE BEEN FULLY INSERTED INTO THE PANEL AT THE CORRECT ANGLE WITHOUT USING THE DRILL SLEEVE. THIS PREVENTS THE LOCKING OF THE LOCKING SCREWS. ANOTHER POSSIBLE CAUSE IS THAT THE SCREWS WERE NOT SUFFICIENTLY TIGHTENED AND THEREFORE COULD NOT LOCK ADEQUATELY IN THE PLATE. THE IMPLANTS WERE NOT AVAILABLE FOR EXAMINATION. THE CASES HAD ALREADY OCCURRED SEVERAL MONTHS PREVIOUSLY AT THE TIME OF REPORTING.

    Description of Event or Problem · 0

    DURING RECONSTRUCTIVE SURGERY ON THE DISTAL FEMUR AND PROXIMAL TIBIA, AN OSTEOTOMY WAS PERFORMED ON THE FEMUR. APPROXIMATELY FOUR MONTHS AFTER THE PROCEDURE, A RADIOLOGIC FOLLOW-UP REVEALED A FAILURE OF THE INTERNAL FIXATION, WHICH LED TO A LOSS OF REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374677 LOQTEQ® DISTAL FEMURPLATE 4.5 BONE PLATES HRS AAP IMPLANTATE AG PF 4510-07-2 T009

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Required Intervention