BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 25297695 · Received May 27, 2026

    Report

    Report Number
    3005180920-2026-00532
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 MAY 2026: MECTACER 01.29.212 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-S (K112115) LOT. 2528827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2025. EXPIRATION DATE: 2030-NOV-02. 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. MPACT 01.32.4048HCT FLAT PE HC LINER D 40/F (K122641) LOT. 2526525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2025. EXPIRATION DATE: 2030-OCT-21. 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

    REVISION SURGERY DUE TO JOINT LUXATION AFTER 8 DAYS FROM PRIMARY. THE CERAMIC HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE 40MM BIOLOX S HEAD WITH A SAME SIZE HEAD, AND REVISED THE FLAT PE HC D 40/F LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289436 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.40 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.212 2528827 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1