BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER CERAMIC BALL HEAD

    MDR report key: 7163363 · Received January 4, 2018

    Report

    Report Number
    3005180920-2017-00817
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    December 8, 2017
    Report Date
    February 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02 FEBRUARY 2018 R&D PRODUCT MANAGER ANALYZED THE ITEM RECEIVED AND COMMENTED: THE CERAMIC BALL HEAD WAS ANALYZED BUT DID NOT SHOW ANY PARTICULAR SIGN OF FAILURE OF THE DEVICE; SOME SIGNS DUE TO THE REVISION WERE NOTICED ON THE SURFACE AND SOME YELLOW AREAS, PROBABLY SOLIDIFIED ADIPOSE TISSUE OCCURRED DURING REVISION SURGERY, WAS PRESENT IN SOME SMALL AREAS. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON SWAPPED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018: LOT 172270: 102 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022 NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 72 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON SWAPPED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9329 MECTACER CERAMIC BALL HEAD CERAMIC FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 172270 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention