BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER X-LONG

    MDR report key: 15212380 · Received August 11, 2022

    Report

    Report Number
    3010536692-2022-00284
    Event Type
    Injury
    Date Received
    August 11, 2022
    Report Date
    October 13, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    UDI-DI
    M684260000281
    PMA / PMN Number
    K004043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT UNDERWENT LEFT THR ON (B)(6) 2022. REVISED ON (B)(6) 2022 DUE TO INFECTION. PERFORMED WASHOUT AND CHANGE OF LINER AND FEMORAL HEAD. SURGICAL SPECIALTIES REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945189 COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER X-LONG HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. 26000028 1776822 M684260000281

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male