BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIATOR® G26 BIPOLAR

    MDR report key: 20108350 · Received August 30, 2024

    Report

    Report Number
    3010536692-2024-00434
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    August 7, 2024
    Report Date
    November 12, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, ONLY GLADIATOR 26 BIPOLAR CUP VER. 2 49MM RETURN. CONFIRMED THAT IT WAS NOT DUE TO TRAUMA. SALES REP CHECKED THE CUP AND THERE DID NOT SEEM TO BE ANY PROBLEM. POSSIBLE SOFT-TISSUE INTER-POSITIONAL TRANSPOSITION. NON REVISED PRODUCTS: PRODUCT ID: PHA00242 PROFEMUR® Z STEM SIZE 6/ LOT NO.: 1958624/ QTY:(B)(4) PRODUCT ID: 26012602 FEMORAL HEAD 26 MM 0 MM/ LOT NO.: 2001498/ QTY: (B)(4) PRODUCT ID: PHA01202 PROFEMUR® MODULAR FEMORAL NECK/ LOT NO.: 1999027/ QTY: (B)(4). JAPAN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315177 GLADIATOR® G26 BIPOLAR HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. GLJG2649 1952466

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Male Required Intervention