BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22849203 · Received August 20, 2025

    Report

    Report Number
    3005180920-2025-00788
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 20, 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 05-AUG-2025: 01.29.214 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-L (K112115) LOT: 2404447 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-03-2024 EXPIRATION DATE: 2029-02-19. 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 05-AUG-2025: LINER: MECTACER 01.32.4052HC4 OFFSET 4MM PE HC LINER Ø40/G (K183582) LOT. 2210002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-06-2022 EXPIRATION DATE: 2027-05-30. 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. STEM: M-VIZION 01.22.428 PROXIMAL BODY Ø24MM L 50MM LAT WITH HOLES (K201471) LOT: 2319369: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-02-2024 EXPIRATION DATE: 2029-01-23. 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. CONCLUSIONS: 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 10 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN THAT WAS DETERMINED BY THE SURGEON TO BE A RESULT OF INFECTION WITH AN UNKNOWN CAUSE. THE SURGEON REVISED THE PROXIMAL BODY, FEMORAL HEAD AND LINER IN ADDITION TO PERFORMING A WASHOUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155532 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 40 SIZE L LZO MEDACTA INTERNATIONAL SA 01.29.214 2404447 07630030809255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention