BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S - 4

    MDR report key: 12467900 · Received September 14, 2021

    Report

    Report Number
    3005180920-2021-00733
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2021: LOT 2002617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JULY-2020. EXPIRATION DATE: 2025-JULY-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL INFORMATION: THE REVISED LINER WAS FROM COMPETITOR.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 10 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363326 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S - 4 FEMORAL CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.212 2002617 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention