BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23669495 · Received November 28, 2025

    Report

    Report Number
    3005180920-2025-01209
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    November 13, 2025
    Report Date
    November 28, 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 17 NOV 2025. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S LOT. 2517226: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JULY 2025. EXPIRATION DATE: 25 JUNE 2030. 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 01.32.3648HCT FLAT PE HC LINER D 36/F (K1037219) LOT. 2504985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2025. EXPIRATION DATE: 24 MARCH 2030. 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 THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE. ALTHOUGH IT CANNOT BE CONFIRMED, THE ISSUES REPORTED MAY HAVE RESULTED FROM APPLICATION SPECIFIC FACTORS AND/OR DAMAGE OF THE PARTICULAR COMPONENTS INVOLVED. NO SYSTEMIC ISSUE CAN BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ONE MONTH AFTER THE PRIMARY SURGERY DUE TO JOINT LUXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265325 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.208 2517226 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention