BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24208591 · Received January 29, 2026

    Report

    Report Number
    3005180920-2026-00081
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 12, 2026
    Report Date
    January 29, 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 23 JAN 2026. BALL HEADS: MECTACER 01.29.213 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M LOT. 2525203: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2025.EXPIRATION DATE: 2030-SEPT-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. LINER: MPACT 01.32.4048HCT FLAT PE HC LINER D 40/F (K122641) LOT. 2517765: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEPT-2025.EXPIRATION DATE: 2030-AUG-24. 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

    REVISION SURGERY AFTER 1 MONTH POST-PRIMARY DUE TO INFECTION. THE SURGEON REVISED THE LINER AND THE HEAD TO ADDRESS THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276765 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.213 2525203 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention