BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M

    MDR report key: 11493345 · Received March 16, 2021

    Report

    Report Number
    3005180920-2021-00201
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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.FEB.2021: LOT 2002611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JUN-2020. EXPIRATION DATE: 2025-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    HOLD FOR KP 3.16.21 THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY REPORTING PAIN AND DISCOMFORT DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD M WITH A 36MM COCR HEAD XXL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388989 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2002611 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention