BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M

    MDR report key: 22999145 · Received September 8, 2025

    Report

    Report Number
    3010536692-2025-00317
    Event Type
    Injury
    Date Received
    September 8, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHA044161
    PMA / PMN Number
    K130376
    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, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: M. OTHER LEGAL MANUFACTURER: PRODUCT ID: 321.05.936 TRINITY LINER (HXLPE) 036MM NEUTRAL 4MM EPW TAPER SIZE 5 CORIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522803 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04416 2045102 M684PHA044161

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention