BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23920166 · Received December 30, 2025

    Report

    Report Number
    3005180920-2025-01344
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 23, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-DEC-2025. BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT. 2339382: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2023 EXPIRATION DATE: 2028-10-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 DEG; PE HC LINER D 36/E (K183582) LOT. 2009675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020 EXPIRATION DATE: 2025-11-17. 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

    AT ABOUT 1 YEAR AND 9 MONTHS FROM PRIMARY THE PATIENT REPORTED INSTABILITY DUE TO LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER TO XXL HEAD AND DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259905 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.209 2339382 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention