BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24603557 · Received March 16, 2026

    Report

    Report Number
    3005180920-2026-00207
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 FEBRUARY 2026: LOT 2513924: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2025. EXPIRATION DATE: 2030-MAY-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY, AT 6 MONTHS FROM PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON ELECTED TO UPSIZE THE 40MM BIOLOX M HEAD TO A 40MM BIOLOX XL HEAD TO ADDRESS THE DISCREPENCY. THE SURGERY WAS COMPLETED SUCCESSFULLY. AI: IMPLANTED - 01.29.215 40MM BIOLOX DELTA HEAD XL 2101468.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667240 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.213 2513924 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention