BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15542030 · Received October 5, 2022

    Report

    Report Number
    3005180920-2022-00741
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2022. LOT 2002617: 90 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: 2025-JUL-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598898 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S HIP CERMAIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.212 2002617 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention