BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21899448 · Received April 24, 2025

    Report

    Report Number
    3005180920-2025-00302
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809255
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02-04-2025 LOT 1909766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-03-2020. EXPIRATION DATE: 2025-02-18. 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 IMPLANTS REVISED BATCH REVIEW PERFORMED ON 02-04-2025 ON STEM: M-VIZION 01.22.022 PROXIMAL BODY Ø24MM L 50MM STD (K191816) LOT. 1901178. LOT 1901178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-11-2019. EXPIRATION DATE: 2024-11-16. 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. BATCH REVIEW PERFORMED ON 02-04-2025 ON STEM: M-VIZION 01.22.167 DISTAL STEM Ø18MM L 220MM STRAIGHT (K191816) LOT. 1901254. LOT 1901254: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-10-2019. EXPIRATION DATE: 2024-09-25. 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. 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 YEARS AND 3 MONTHS 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 MEDACTA STEM AND HEAD AND COMPETITOR HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480474 MECTACER BIOLOX DELTA FEMORAL BALL HEAD BALL HEADS: MECTACER MECTACER HEAD BIOLOX DELTA DIA.40 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.214 1909766 07630030809255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention