BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 20705351 · Received November 18, 2024

    Report

    Report Number
    3005180920-2024-00963
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    October 22, 2024
    Report Date
    November 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    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 31 OCTOBER 2024: LOT 2100273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 31 OCTOBER 2024 LINER: MPACT 01.32.3641HC4 OFFSET 4MM PE HC LINER Ø36/D (K183582) LOT 2347433: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-FEB-2024. EXPIRATION DATE: 2029-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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

    AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611116 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 LZO MEDACTA INTERNATIONAL SA 01.29.210 2100273 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention