BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M

    MDR report key: 16443283 · Received February 27, 2023

    Report

    Report Number
    3010536692-2023-00025
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 1, 2023
    Report Date
    June 9, 2023
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHA044161
    PMA / PMN Number
    K130376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, PACKAGING AND CONTENT DIDN'T MATCH... INSIDE THE 36MM MEDIUM HEAD PACKAGING, WAS AN 28MM SMALL HEAD AS CONTENT. WE OPENED ANOTHER ONE (PHA04416 WITH LOT 1920149) FOR THIS SURGERY, WHICH WAS RIGHT LABELED AND PACKED. THIS EVENT HAS BEEN A TRIGGER FOR THE CREATION OF A DPRA. DUE TO THIS DPRA IT IS CONSIDERED THAT THIS INCIDENT SHOULD BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787186 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04416 1950403 M684PHA044161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention