BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 10353177 · Received July 31, 2020

    Report

    Report Number
    3010536692-2020-00537
    Event Type
    Injury
    Date Received
    July 31, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012321
    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: PPR67352 COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 52 LOT U1088757, PPR6-7612 TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 13D LOT 098634518. PPR67510 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
    814315 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01232 018531248 M684PHA012321

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention