BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23837296 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01241
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 18, 2025
    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 04-DEC-2025. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT 2508313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2025 EXPIRATION DATE: 2030-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 105 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2515749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2025 EXPIRATION DATE: 2030-06-10. 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

    AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION. THE SURGEON PERFORMED A WASHOUT WITH A HEAD AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618616 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.208 2515749 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention