BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L

    MDR report key: 18750361 · Received February 21, 2024

    Report

    Report Number
    3010536692-2024-00088
    Event Type
    Injury
    Date Received
    February 21, 2024
    Report Date
    February 21, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHA044061
    PMA / PMN Number
    K140043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, DISLOCATION/SUBLUXATION, SIDE: R, REVISION NJR: 4170729, GENDER: F, EXPLANTED: ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER (ONLY THE HEAD IS AN MPO COMPONENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62259 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04406 W11373380 M684PHA044061

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention