BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21975647 · Received May 7, 2025

    Report

    Report Number
    3005180920-2025-00363
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-04-2025. LOT 2434508: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-01-2025. EXPIRATION DATE: 2029-12-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    ABOUT TWO WEEKS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469059 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 36 SIZE L LZO MEDACTA INTERNATIONAL SA 01.29.210 2434508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention