BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22607935 · Received July 25, 2025

    Report

    Report Number
    3005180920-2025-00707
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-JUL-2025. LOT 2505475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-03-2025. EXPIRATION DATE: 2030-02-25. 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. ADDITIONAL COMPONENT REVISED: BATCH REVIEW PERFORMED ON 11-JUL-2025. STEM: M-VIZION 01.22.427 PROXIMAL BODY Ø24MM L 40MM LAT WITH HOLES (K201471) LOT 2348621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-05-2024. EXPIRATION DATE: 2029-05-15. 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. COMPETITOR CUP AND LINER REVISED. 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 2 WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR CUP AND LINER AND MEDACTA PROXIMAL BODY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199272 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.202 2505475 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention