BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM

    MDR report key: 14021216 · Received April 6, 2022

    Report

    Report Number
    3010536692-2022-00098
    Event Type
    Injury
    Date Received
    April 6, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M68438AM54351
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, REMOVED THE HEAD FOR SUSPECTED METALLOSIS AND PSEUDO-TUMOR. PRODUCTS NOT REVISED: PRODUCT: PROFEMUR LX STEM PRODUCT ID: PRLX0015, LOT#: 106380377; PRODUCT: PROFEMUR NECK 8DG VAR/NAL SHORT PRODUCT ID: PHA01252, LOT#: 086371800.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489339 CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. 38AM5435 106385199 M68438AM54351

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention