BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M

    MDR report key: 20062473 · Received August 26, 2024

    Report

    Report Number
    3005180920-2024-00671
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    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 06-AUG-2024: LOT 2401464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2024. EXPIRATION DATE: 2029-01-14. 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 DEVICE INVOLVED, BATCH REVIEW PERFORMED ON 06-AUG-2024. LINER: IMPACT 01.32.4048HC10A FACE-CHANGING 10° PE HC LINER Ø40/F (K183582) LOT 2246044: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2023. EXPIRATION DATE: 2028-01-27. 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.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230982 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2401464 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention