BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24162753 · Received January 23, 2026

    Report

    Report Number
    3005180920-2026-00043
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 8, 2026
    Report Date
    January 23, 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 12 JAN 2026. LINER: MPACT 01.32.4052HCT FLAT PE HC LINER D 40/G (K122641) LOT. 2508241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JUL 2025. EXPIRATION DATE: 16 JUN 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. NO NONCONFORMITIES OR ANOMALIES WERE RECORDED DURING PRODUCTION OR POST-MARKET ACTIVITIES. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS 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 AFTER 1 MONTH AFTER THE PRIMARY DUE TO A DISLOCATION OF THE HEAD AND LINER.THE SURGEON REVISED THE HEAD, LINER, AND CUP TO A DOUBLE MOBILITY SYSTEM TO PREVENT DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228285 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.213 2515758 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention