BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24376303 · Received February 18, 2026

    Report

    Report Number
    3005180920-2026-00104
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 18, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 FEBRUARY 2026: BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2517546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2025. EXPIRATION DATE: 2030-JUL-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 93 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HC10A FACE CHANG 10° PE HC LINER D 36/E (K183582) LOT 2430443: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2025. EXPIRATION DATE: 2030-JAN-30. 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: 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

    THE PATIENT HAD A HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND HEAD TO A SAME SIZE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439501 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.208 2517546 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention