BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L

    MDR report key: 10353320 · Received July 31, 2020

    Report

    Report Number
    3010536692-2020-00538
    Event Type
    Injury
    Date Received
    July 31, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHA044061
    PMA / PMN Number
    K140043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION+BONE FRACTURE. COMPONENTS NOT REVISED: (B)(4) COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 52 LOT U1088757. (B)(4) TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 13D LOT 098634518. (B)(4) INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE LOT U11145690.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817921 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04406 W10381235 M684PHA044061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention